A Phase 1 interventional study of KIVU-107 in Advance Solid Tumors, sponsored by Kivu Bioscience Inc.. Recruiting at 7 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Kivu Bioscience Inc. · Phase 1, Interventional, and Treatment
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Among 260 studies in Neoplasm Metastasis with a site in Australia — 61 open to participants now, 106 under way, 34 of them phase 3. Neoplasm Metastasis · Australia.
Among the 260 studies in Neoplasm Metastasis with a site in Australia, this one is the 193rd largest by planned enrollment of the 253 interventional ones that give a count, is one of 18 that started in 2025, is one of 67 in phase 1, reaches primary completion later than 75 of the 105 other live ones, and was the 245th registered.
4,045 studies on the registry are indexed under Neoplasm Metastasis; 888 are open to participants now.
Browse Neoplasm Metastasis studies →61 of the 260 studies in Neoplasm Metastasis with a site in Australia are open now. Recruiting first, the newest first:
BrYet US, Inc. · Sites in Australia
Ages 18+
BeOne Medicines · Sites in Australia, New Zealand
Ages 18+
Second Life Therapeutics · Sites in Australia
Ages 18+
Eilean Therapeutics · Sites in Australia, Uzbekistan
Ages 18+
Immuneering Corporation · Sites in Australia, United States, Georgia and 6 more countries
Ages 18+
A study can be open while its sites in Australia have not opened yet or have stopped. Only those recruiting at a site in Australia →
Of the 689 Neoplasm Metastasis studies recruiting now, 536 (78%) set no upper age limit and 97 (14%) stop at 75 or younger; 48 take children under 18; 18 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
260 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 111 · Phase 2 101 · Phase 3 91 · Phase 4 1
First in 1996; this study’s year is marked. 18 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 76 is above the median of 50 across 3,270 interventional studies indexed under Neoplasm Metastasis.
Median enrollment 227 across the 253 interventional studies, 1,263 across the 2 observational. Of the 145 that completed or were terminated, 77 (53%) have results posted.
This tab as a report to print or save as PDF → With an account.
227 of 260 have an industry lead sponsor. The 10 most frequent:
Kivu Bioscience Inc. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Kivu Bioscience Inc. has 1 study filed under Neoplasm Metastasis — fewer than ten, so there is no comparison to draw.
31 of the studies in Neoplasm Metastasis with a site in Australia that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06103864Phase 3AstraZenecaA Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05) | 2027-07-28 |
| NCT06064877Phase 3AVEO Pharmaceuticals, Inc.A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma | 2027-08 |
| NCT07044336Phase 3AstraZenecaPuxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01) | 2027-10-15 |
| NCT06119581Phase 3Eli Lilly and CompanyA Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer | 2027-11 |
| NCT05544552Tyra Biosciences, IncSafety and Preliminary Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors With FGFR3 Gene Alterations | 2026-11 |
Add all 31 to your calendar (.ics) → With an account.
Among the 260 studies in Neoplasm Metastasis with a site in Australia, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a 2-part, first-in-human, open-label study to determine the safety and tolerability of KIVU-107, a PTK7-directed antibody-drug conjugate, in participants with locally advanced or metastatic solid tumors.
Part A: The primary objective of Part A of this study is to evaluate the safety and tolerability of KIVU-107 and to determine the maximum tolerated dose (MTD)/Recommended Dose for Expansion (RDE).
Part B: The primary objective of Part B of this study is to confirm the safety and tolerability of KIVU-107 at the RDE.
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.
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 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.
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.
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 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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Part A: KIVU-107 Dose Finding - Participants will be treated with KIVU-107 in multiple ascending cohorts.
Drug: KIVU-107
Part B: KIVU-107 Dose Expansion - Participants will be treated with the RDE from Part A.
Drug: KIVU-107
KIVU-107 will be administered IV.
Part A (Dose Finding): To determine the Maximum Tolerated Dose (MTD)
Number of participants with treatment emergent adverse events
Time frame: Up to 18 months
Number of participants with treatment related adverse events as assessed by CTCAE version 5.0
Time frame: Up to 18 months
To evaluate safety and tolerability of KIVU-107
Number of participants with treatment related adverse events as assessed by CTCAE v5.0
Time frame: Up to 30 months
Objective Response Rate (ORR) is percentage of participants with best response of complete response (CR) or partial response (PR) according to RECIST 1.1
Time frame: Up to 30 months
Duration of Response (DOR)
Time from CR or PR to objective disease progression or death to any cause
Time frame: Up to 30 months
To evaluate the immunogenicity as measured by change of anti-drug antibodies in participants treated with KIVU-107
Time frame: Up to 30 months
Maximum Serum concentration of KIVU-107 (Cmax)
PK assessment
Time frame: 21 days
Maximum serum concentration of KIVU-107 (Cmin)
PK assessment
Time frame: 21 days
Maximum Serum concentration of KIVU-107 at Steady State (Cmax, ss)
PK assessment
Time frame: up to 168 days
Minimum Serum Concentration of KIVU-107 at Steady State (Cmin, ss)
PK assessment
Time frame: up to 168 days
Time of Maximum Serum Concentration of KIVU-107 (Tmax)
PK assessment
Time frame: up to 168 days
Time of Minimum Serum Concentration of KIVU-107 (Tmin)
PK assessment
Time frame: up to 168 days
Time of Minimum Serum Concentration of KIVU-107 (Tmin, ss)
PK assessment
Time frame: Up to 168 days
Terminal Half-Life (t1/2) of Serum KIVU-107
PK assessment
Time frame: Up to 168 days
Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUClast) for KIVU-107
PK Assessment
Time frame: 21 days
Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUCinf) for KIVU-107
PK Assessment
Time frame: Up to 168 days
Clearance (CL) of KIVU-107
PK Assessment
Time frame: Up to 168 days
Apparent volume of distribution during the terminal phase (Vz) of KIVU-107
PK Assessment
Time frame: Up to 168 days
Accumulation ration (Rac) of KIVU-107
PK Assessment
Time frame: Up to 168 days
To evaluate biomarkers with potential to predict response and/or resistance to KIVU-107 characterize baseline levels and/ or changes in genomic, mRNA and/or protein biomarkers to determine any signatures correlated with response or resistance.
Time frame: Up to 30 months
Progression Free Survival (PFS) is defined as the time from the first dose to either disease progression according to RECIST v. 1.1, or death due to any cause, whichever comes first.
Time frame: Up to 30 months
Overall Survival (OS)
Proportion of participants alive at 1 year from the start of treatment to death from any cause
Time frame: Up to 30 months
Time to Response (TTR)
Time from start of treatment to complete response or partial response
Time frame: Up to 30 months
Disease Control Rate (DCR)
Proportion of participants with CR, PR, or SD
Time frame: Up to 30 months
Plan to share: No — We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research.
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Mar 2028, 28 months after the start.
Of 286 industry-sponsored phase 1 interventional studies under Neoplasm Metastasis, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 75. This study's planned 28 months is below that.
Counting every sponsor, half of 496 studies reached it within 54 months; a quarter within 33 and three quarters within 83.
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.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Kivu Bioscience Inc.