A Phase 1/2 interventional study of CR-002 in Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M), Gastric/GEJ and Biliary Tract Cancer (BTC), sponsored by Crescent Biopharma, Inc.. Recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Crescent Biopharma, Inc. · Phase 1/2, Interventional, and Treatment
The purpose of this study is to determine the safety and tolerability of monotherapy CR-002 and to identify the MTD and/or optimal biologic dose and RP2D(s) in participants with locally advanced or metastatic solid tumors.
The study will initially comprise 2 parts: dose escalation (Part 1) and backfill (Part 2). Population-defined dose optimization (Part 3) and expansion (Part 4) cohorts may be added based on emerging data.
Part 1: The study will follow a stepwise approach, beginning with a typical dose escalation in participants with selected indications of advanced solid tumors.
Part 2: Additional participants will enroll in the backfill part at select dose levels that have been previously cleared for safety by the safety review committee.
All participants will undergo a screening period, a treatment period, a safety follow-up period, and long-term follow-up. During the treatment period, participants will undergo clinical and safety assessments including disease assessment scans and blood laboratory safety, and pharmacokinetic assessments. After treatment ends, disease scans will continue until disease progression, and long-term follow-up visits will be conducted by telephone every 3 months.
2,018 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.
This study's planned enrollment of 219 is above the median of 48 across 1,653 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Browse Squamous Cell Carcinoma of Head and Neck studies →Crescent Biopharma, Inc. is the lead sponsor of 2 studies on the registry; 2 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.
Is progressing from, intolerant to, or ineligible for (due to unavailability or ) local standard of care therapies and have one of the following locally advanced or tumor types:
Exclusion Criteria:
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.
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 amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
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.
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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.
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.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
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.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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.
Escalating dose levels of CR-002 will be tested to define the maximum tolerated dose of CR-002 in participants with locally advanced or metastatic solid tumors who are refractory to or unable to tolerate standard of care treatment, or for whom standard of care treatment is unavailable.
Drug: CR-002
Escalating dose levels of CR-002 will be tested in indication-specific cohort populations.
Drug: CR-002
Intravenous Infusion
Part 1: Dose Escalation - incidence and nature of dose-limiting toxicities
Per cohort
Time frame: From the first dose of study drug up until approximately 1 month
Part 1: Dose Escalation - characterization of the maximum tolerated dose, if applicable
Per cohort
Time frame: From the first dose of study drug up until approximately 1 month
All Parts - incidence, nature, and severity of treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events
Events are graded according to National Cancer Institute Cancer Terminology Criteria for Adverse Events (NCI CTCAE)
Time frame: From the first dose of study drug until 90 days after the last dose of study drug
All Parts - incidence and severity of TEAEs leading to dose modifications
Time frame: From the first dose of study drug until 90 days after the last dose of study drug
All Parts - incidence and severity of TEAEs leading to treatment discontinuation
Time frame: From the first dose of study drug until 90 days after the last dose of study drug
All Parts - determination of recommended phase 2 dose(s)
Time frame: From the first dose of study drug until 90 days after the last dose of study drug
All Parts - serum CR-002 pharmacokinetic parameters
AUC0-inf after a single dose and steady state parameters, as appropriate
Time frame: Predose until up to approximately 36 months
All Parts - serum CR-002 pharmacokinetic parameters
AUClast after a single dose and steady state parameters, as appropriate
Time frame: Predose until up to approximately 36 months
All Parts - serum CR-002 pharmacokinetic parameters
Cmax after a single dose and steady state parameters, as appropriate
Time frame: Predose until up to approximately 36 months
All Parts - serum CR-002 pharmacokinetic parameters
Tmax after a single dose and steady state parameters, as appropriate
Time frame: Predose until up to approximately 36 months
All Parts - serum CR-002 pharmacokinetic parameters
Vd after a single dose and steady state parameters, as appropriate
Time frame: Predose until up to approximately 36 months
All Parts - serum CR-002 pharmacokinetic parameters
CL after a single dose and steady state parameters, as appropriate
Time frame: Predose until up to approximately 36 months
All Parts - serum CR-002 pharmacokinetic parameters
t½ after a single dose and steady state parameters, as appropriate
Time frame: Predose until up to approximately 36 months
All Parts - incidence of participants with detectable antidrug antibodies
Time frame: Predose until up to approximately 36 months
All Parts - overall response rate (ORR)
Time frame: Predose until up to approximately 36 months
All Parts - duration of response (DOR)
Time frame: Predose until up to approximately 36 months
All Parts - disease control rate (DCR)
Time frame: Predose until up to approximately 36 months
All Parts - clinical benefit rate (CBR)
Time frame: Predose until up to approximately 36 months
All Parts - time to response (TTR)
Time frame: Predose until up to approximately 36 months
All Parts - progression free survival (PFS)
Time frame: Predose until up to approximately 36 months
All Parts - overall survival (OS)
Time frame: Predose until up to approximately 36 months
All Parts - best percent change in target lesions
Time frame: Predose until up to approximately 36 months
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Crescent Biopharma, Inc.