A Phase 1/2 interventional study of TT-702 and Anti-PD-1 and PD-L1 agent in Advanced Solid Tumors, sponsored by Cancer Research UK. Recruiting at 3 sites in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Cancer Research UK · Phase 1/2, Interventional, and Treatment
This clinical trial is evaluating the drug candidate TT-702 in patients with advanced solid tumours. The main aims of the trial are to determine the maximum dose of TT-702 that can be given safely to patients alone and in combination with other anti-cancer agents.
TT-702 is a 'small molecule prodrug'. TT-702 is converted into TT-478, which then targets and blocks the function of the 'A2B adenosine receptor'. It is hoped that by blocking this receptor the immune system will become more active in recognising and removing tumour cells.
This clinical trial has two phases:
The main aims of this trial are to:
1,219 studies on the registry are indexed under Triple Negative Breast Neoplasms; 446 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 1,053 interventional studies indexed under Triple Negative Breast Neoplasms.
Browse Triple Negative Breast Neoplasms studies →Cancer Research UK is the lead sponsor of 83 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Phase I, dose escalation phase
or cytologically proven advanced solid tumours to conventional treatment, or for which no conventional therapy is considered appropriate by the Investigator or is declined by the patient. Phase I dose escalation cohorts are:
MMRd tumour, confirmed by either:
i. Loss of MSH2, MSH6, MLH1, PMS2 by ICH (total or near total) OR ii. Loss of function mutation f MMR gene(s) AND iii. High tumour mutation burden (depends on assay but typically >15 mutations/MB sequenced).
Non-MMRd tumours:
mCRPC: - Prior treatment with a next generation hormonal agent. - Adenocarcinoma without neuroendocrine or small cell features.
TNBC:
- Human epidermal growth factor receptor 2 negativity (negative immunohistochemistry [IHC] staining [score 0 or 1] or negative fluorescence in situ hybridisation based on the American Society of Clinical Oncology/College of American Pathologists guidelines and recommendations) and determined through local testing in NHS lab within UKAS/ISO 15198 scope of accreditation.
CRC, NSCLC and PDAC:
- Histologically or cytologically proven diagnosis of CRC, NSCLC or PDAC
Phase II (expansion phase)
Histologically or cytologically proven advanced solid tumour of particular interest based on preclinical and clinical data, refractory to conventional treatment or, for which no conventional therapy is considered appropriate by the Investigator or, is declined by the patient. Phase II expansion cohorts are:
Cohort 2M (TT-702 Monotherapy expansion cohort) and Cohort 2P (TT-702 \& anti-PD-1/PD-L1 combination cohort):
MMRd tumour, confirmed by either:
i. Loss of MSH2, MSH6, MLH1, PMS2 by IHC (total or near total) OR ii. Loss of function mutation of MMR gene(s) AND iii. High tumour mutation burden (depends on assay but typically >15 mutations/MB sequenced).
Exclusion criteria:
<!-- -->
Women of (or are already pregnant or lactating). However, those patients who meet the following points are considered eligible:
Male patients with partners of childbearing potential. However, those patients who meet the following points are considered eligible:
Concurrent congestive heart failure, prior history of class II-IV cardiac disease ( [NYHA]), prior history of cardiac ischaemia or prior history of clinically significant cardiac arrhythmia. Patients with significant cardiovascular disease are excluded as defined by:
a. History of congestive heart failure requiring therapy (NYHA III or IV); b. History of unstable angina pectoris or myocardial infarction up to six months prior to trial entry (patients with previous cardiac or thrombotic events who are now stable and or recovered are eligible); c. Presence of severe valvular heart disease; d. Presence of a ventricular arrhythmia requiring treatment; e. \< 50%; f. Has a prolongation to >470 milliseconds (ms) based on a 12-lead in triplicate; g. Previous stroke or within 6 months of trial entry; h. History of clinically significant peripheral vascular disease/vasculitis/vasculopathy.
Patients with a known or suspected history of or allergy to TT-702, or any of its (for any strength) are excluded:
If a patient is taking any dietary supplements or complementary medicines/botanicals, the Sponsor's Centre for Drug Development (CDD) must be informed at the earliest opportunity both prior to enrolment and during the patient's time on trial.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This cohort will recruit patients with MMRd tumours or non-MMRd CRC, mCRPC, NSCLC, PDAC, TNBC.
Drug: TT-702
This cohort will recruit patients with MMR defective tumours who have had prior treatment with an immune checkpoint inhibitor (ICI).
Drug: TT-702
This cohort will recruit patients who have had prior treatment with an ICI.
Drug: Anti-PD-1 and PD-L1 agent
This cohort will recruit patients with MMRd tumours who have had prior treatment with an ICI.
Drug: Anti-PD-1 and PD-L1 agent
TT-702 will be administered orally, once daily, for up to 12 months.
An appropriate anti-PD-1/PD-L1 combination agent will be selected and implemented following a substantial amendment.
Number of Dose Limiting Toxicities (DLTs) (Dose Escalation Phase)
Dose Limiting Toxicities to TT-702 are determined by testing increasing doses of TT-702 administered once daily in continuous 21-day cycles in escalation cohorts. Dose limiting toxicities are defined per protocol as a highly probably or probably TT-702-related adverse events (AEs) of neutropenia, thrombocytopenia, non-haematological toxicities, photosensitivity, death or other drug-related toxicity causing TT-702 interruption, occurring during Cycle 0 or Cycle 1 administration.
Time frame: From the first dose in Cycle 0, until completion of Cycle 1 (3 weeks [+ 3-9 days to account for initial pharmacokinetic (PK) profiling period following the Cycle 0 dose]).
Number of Treatment-Emergent AEs (TEAEs), Related TEAEs and Grade 3, 4 or 5 TEAEs (Dose Escalation Phase)
Number of TEAEs, TEAEs related to TT-702 and Grade 3, 4 or 5 TEAEs in the dose escalation phase. AEs are categorised according to Medical Dictionary for Regulatory Activities (MedDRA) and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) versions applicable at time of reporting. AEs are assessed by the reporting study doctors for a causal relationship to TT-702. Related are those AEs with a causality of possible, probable or highly probable. All AEs are collected until the off-study visit, approximately 21 (±7) days after the final dose of TT-702 and TT-702-related AEs present at the off-study visit are to be followed up monthly until resolution, return to baseline, stabilisation or initiation of another anti-cancer treatment.
Time frame: From the time of first dose until the end of the safety follow-up period for TT-702.
Objective Response Rate (ORR)
ORR is defined as the proportion of participants with a confirmed Complete Response (CR) or Partial Response (PR) at 6 months (Expansion Phase) and is used to assess antitumour activity according to PCWG3 or RECIST v1.1 criteria. Responses must be confirmed by repeat assessment ≥4 weeks after initial response criteria are met.
Time frame: From the first dose and until the final radiological disease assessment at the off-study visit.
Number and Percentage of Participants that Achieved Clinical Benefit Assessed by PCWG3 and RECIST v1.1 (Expansion Phase)
Antitumour activity measured according to PCWG3 and RECIST version 1.1. Complete Response or PR/remission is confirmed by repeat measurements ≥4 weeks after response criteria are met; participants with SD are to meet criteria at least once ≥6 weeks after first dose of TT-702. Clinical Benefit Rate is defined as the proportion of participants with absence of disease progression (i.e. confirmed CR, PR or SD) for at least 24 weeks from the start of trial treatment.
Time frame: From the first dose and until the final radiological disease assessment at the off-study visit.
Measurement of Maximum (or Peak) Plasma Concentration (Cmax) of TT-702 and its Active Product, TT-478, as Appropriate (Dose Escalation and Expansion Phase)
Pharmacokinetic parameters are derived from analysing the concentration of TT-702 and its active metabolite, TT-478, in plasma via Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS).
Time frame: From the first dose of TT-702 until the discontinuation visit (max 12 months).
Measurement of Minimal Plasma Concentration (Cmin) of TT-702 and its Active Product, TT-478, as Appropriate (Dose Escalation and Expansion Phase)
Pharmacokinetic parameters are derived from analysing the concentration of TT-702 and its active metabolite, TT-478, in plasma via LC-MS/MS.
Time frame: From the first dose of TT-702 until the discontinuation visit (max 12 months).
Measurement of Time at Cmax (Tmax) of TT-702 and its Active Product, TT-478, as Appropriate (Dose Escalation and Expansion Phase)
Pharmacokinetic parameters are derived from analysing the concentration of TT-702 and its active metabolite, TT-478, in plasma via LC-MS/MS.
Time frame: From the first dose of TT-702 until the discontinuation visit (max 12 months).
Area Under the Curve (AUC) of TT-702 and its active product, TT-478, as appropriate (Dose Escalation and Expansion Phase)
Pharmacokinetic parameters are derived from analysing the concentration of TT-702 and its active metabolite, TT-478, in plasma via LC-MS/MS.
Time frame: From the first dose of TT-702 until the discontinuation visit (max 12 months).
Apparent Clearance of TT-702 and its Active Product, TT-478, as Appropriate (Dose Escalation and Expansion Phase)
Pharmacokinetic parameters are derived from analysing the concentration of TT-702 and its active metabolite, TT-478, in plasma via LC-MS/MS.
Time frame: From the first dose of TT-702 until the discontinuation visit (max 12 months).
Volume of Distribution of TT-702 and its Active Product, TT-478, as Appropriate (Dose Escalation and Expansion Phase)
Pharmacokinetic parameters are derived from analysing the concentration of TT-702 and its active metabolite, TT-478, in plasma via LC-MS/MS.
Time frame: From the first dose of TT-702 until the discontinuation visit (max 12 months).
Terminal Elimination Half-Life (T1/2) of TT-702 and its Active Product, TT-478, as Appropriate (Dose Escalation and Expansion Phase)
Pharmacokinetic parameters are derived from analysing the concentration of TT-702 and its active metabolite, TT-478, in plasma via LC-MS/MS.
Time frame: From the first dose of TT-702 until the discontinuation visit (max 12 months).
Objective Response Rate Defined as the Proportion of Participants with Confirmed CR or PR According to PCWG3 or RECIST v1.1 at 6 Months (Dose Escalation Phase)
Antitumour activity via ORR measured according to PCWG3 (cRPC) and RECIST v1.1 (solid tumours). Complete Response or PR/remission is to be confirmed by repeat measurements ≥4 weeks after response criteria are met.
Time frame: From the first dose until the final radiological assessment at the off-study visit.
Number and Percentage of Participants that Achieved Clinical Benefit Assessed by PCWG3 or RECIST v1.1 (Dose Escalation Phase)
Antitumour activity measured according to PCWG3 (cRPC) and RECIST version 1.1 (solid tumours). Complete response or PR/remission is confirmed by repeat measurements ≥4 weeks after response criteria are met; participants with SD are to meet criteria at least once ≥6 weeks after first dose of TT-702. Clinical benefit rate is defined as the proportion of participants with absence of disease progression (i.e. confirmed CR, PR or SD) for at least 24 weeks from the start of trial treatment.
Time frame: From the first dose and until the final radiological disease assessment at the off-study visit.
Objective Response Rate Defined as the Proportion of Participants with Confirmed CR or PR According to PCWG3 or RECIST v1.1 at Cycles 3, 6, 9, 12 (Dose Escalation and Expansion Phase)
Antitumour activity measured according to PCWG3 (cRPC) and RECIST version 1.1 (solid tumours). Complete response or PR/remission is confirmed by repeat measurements ≥4 weeks after response criteria are met.
Time frame: From the first dose and until the final radiological disease assessment at the off-study visit.
Objective Response Rate Defined as the Proportion of Participants with Confirmed CR or PR According to PCWG3 or RECIST v1.1 at Any Timepoint (Dose Escalation and Expansion Phase)
Antitumour activity measured according to PCWG3 (cRPC) and RECIST version 1.1 (solid tumours). Complete response or PR/remission is confirmed by repeat measurements ≥4 weeks after response criteria are met.
Time frame: From the first dose and until the final radiological disease assessment at the off-study visit.
Median Duration of Response and 90% Confidence Interval for Participants that Achieved a Confirmed Response (Dose Escalation and Expansion Phase)
Antitumour activity measured according to PCWG3 (cRPC) and RECIST version 1.1 (solid tumours). Complete response or PR/remission is confirmed by repeat measurements ≥4 weeks after response criteria are met. Duration of response is defined as the time from the first observation of CR or PR to PD or death from any cause in participants with confirmed CR or PR.
Time frame: From the first dose and until the final radiological disease assessment at the off-study visit.
Median Duration of Clinical Benefit and 90% Confidence Interval for Participants that Achieved Clinical Benefit (Dose Escalation and Expansion Phase)
Antitumour activity measured according to PCWG3 (cRPC) and RECIST version 1.1 (solid tumours). Complete response or PR/remission is confirmed by repeat measurements ≥4 weeks after response criteria are met; participants with SD are to meet criteria at least once ≥6 weeks after first dose of TT-702. Duration of clinical benefit is defined as duration from date of first administration of TT-702 to PD or death from any cause in participants with confirmed CR, PR or SD for at least 24 weeks from date of administration of the first dose of TT-702.
Time frame: From the first dose and until the final radiological disease assessment at the off-study visit.
Number and Percentage of Participants who Remained Progression Free at 6 Months with 90% Confidence Intervals (Dose Escalation and Expansion Phase)
Antitumour activity measured according to PCWG3 (cRPC) and RECIST version 1.1 (solid tumours). Complete or partial response/remission is confirmed by repeat measurements ≥4 weeks after response criteria are met; participants with SD met criteria at least once ≥6 weeks after first dose of TT-702.
Time frame: From the first dose and until confirmation of progression, at the 6-month timepoint.
Number and Percentage of Participants who are Alive at 12 Months with Associated 90% Confidence Intervals (Dose Escalation and Expansion Phase)
Overall survival of participants at the 12 month post-first dose timepoint.
Time frame: From the first dose and until confirmation of alive or deceased from any cause, at the 12-month timepoint.
Number of TEAEs, related TEAEs, and Grade 3, 4 or 4 TEAEs (Dose Expansion Phase)
Number of TEAEs, TEAEs related to TT-702 and Grade 3, 4 or 5 TEAEs in the dose expansion phase. Adverse events are categorised according to MedDRA and graded for severity according to NCI CTCAE versions applicable at time of reporting. Adverse events are assessed by the reporting study doctors for a causal relationship to TT-702. Related are those AEs with a causality of possible, probable or highly probable. All AEs are collected until the off-study visit, approximately 21 (±7) days after the final dose of TT-702 and TT-702-related AEs present at the off-study visit are to be followed up monthly until resolution, return to baseline, stabilisation or initiation of another anti-cancer treatment.
Time frame: From the time of first dose until the end of the safety follow-up period for TT-702.
Plan to share: No
Started Jan 2022 (actual). Primary completion is estimated for Apr 2028, 75 months after the start.
Of 118 phase 1/2 interventional studies under Triple Negative Breast Neoplasms, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 43 and three quarters within 79. This study's planned 75 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Triple Negative Breast Neoplasms →
Cancer Research UK