Advance Solid TumorsPhase 1NCT07229313
A Study of KIVU-107 in Participants With Locally Advanced or Metastatic Solid Tumors
A Phase 1 study testing KIVU-107 in people with Advance Solid Tumors, run by Kivu Bioscience Inc. at 7 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advance Solid Tumors
- What is being tested?
- KIVU-107
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 13 Nov 2025to 31 Mar 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥18 years of age
- No therapy of proven efficacy exists for the tumor
- Pathologically or histologically documented diagnosis of advanced / metastatic solid tumor malignancy that is resistant to standard therapy or for which no standard therapy is available.
- Adequate bone marrow, kidney, and liver function
- Measurable disease using RECIST v1.1
- ECOG 0 or 1
- Life expectancy ≥ 3 months
Who cannot join
- Prior treatment with any ADC with topoisomerase 1 inhibitor payload
- Any PTK7 - targeted therapy
- Uncontrolled cardiovascular disease
- Active Hepatitis B, Hepatitis C, or HIV infection
- History of interstitial lung disease
- Major surgery, radiation therapy, or systemic anti-cancer within 3 weeks of study treatment start.
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 2 countries
Australia5 sites, 5 recruiting
- Recruiting
Kivu Trial Site
Adelaide, South Australia
- Recruiting
Kivu Trial Site
Brisbane, Queensland
- Recruiting
Kivu Trial Site
Camperdown, New South Wales, 2050
- Recruiting
Kivu Trial Site
Geelong, Victoria
- Recruiting
Kivu Trial Site
Sydney, New South Wales
United States2 sites, 2 recruiting
- Recruiting
Kivu Trial Site
New Have, Connecticut, 06520
- Recruiting
Kivu Trial Site
Santa Monica, California, 90403
About this study
Official title: A Phase 1 Dose-Finding and Dose-Expansion Study of KIVU-107 in Participants With Locally Advanced or Metastatic Solid Tumors
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.
Read the detailed description
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.
- Conditions
- Advance Solid Tumors
- Being tested
- KIVU-107
- Keywords
- PTK7, ADC, solid tumors, PTK-7 expression, metastatic, locally advanced, PTK7 expression, endometrial cancer, ovarian cancer, breast cancer, cervical cancer, GI/GEJ adenocarcinoma, esophageal squamous cell cancer, colorectal cancer, pancreatic cancer, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell carcinoma, sarcoma, OvCa
- Medical subject headings
- Neoplasm Metastasis, Endometrial Neoplasms, Ovarian Neoplasms, Breast Neoplasms, Uterine Cervical Neoplasms, Esophageal Squamous Cell Carcinoma, Colorectal Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KIVU-107Drug
KIVU-107 will be administered IV.
| Study group | Role | What they receive |
|---|---|---|
| Dose Finding | Experimental | Part A: KIVU-107 Dose Finding - Participants will be treated with KIVU-107 in multiple ascending cohorts. Receives: Drug: KIVU-107 |
| Dose Expansion | Experimental | Part B: KIVU-107 Dose Expansion - Participants will be treated with the RDE from Part A. Receives: Drug: KIVU-107 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A (Dose Finding): To determine the Maximum Tolerated Dose (MTD)
Number of participants with treatment emergent adverse events
Measured: Up to 18 months
Number of participants with treatment related adverse events as assessed by CTCAE version 5.0
Measured: 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
Measured: Up to 30 months
Secondary outcomes (16)
Objective Response Rate (ORR) is percentage of participants with best response of complete response (CR) or partial response (PR) according to RECIST 1.1
Measured: Up to 30 months
Duration of Response (DOR)
Time from CR or PR to objective disease progression or death to any cause
Measured: Up to 30 months
To evaluate the immunogenicity as measured by change of anti-drug antibodies in participants treated with KIVU-107
Measured: Up to 30 months
Maximum Serum concentration of KIVU-107 (Cmax)
PK assessment
Measured: 21 days
Maximum serum concentration of KIVU-107 (Cmin)
PK assessment
Measured: 21 days
Maximum Serum concentration of KIVU-107 at Steady State (Cmax, ss)
PK assessment
Measured: up to 168 days
Minimum Serum Concentration of KIVU-107 at Steady State (Cmin, ss)
PK assessment
Measured: up to 168 days
Time of Maximum Serum Concentration of KIVU-107 (Tmax)
PK assessment
Measured: up to 168 days
Time of Minimum Serum Concentration of KIVU-107 (Tmin)
PK assessment
Measured: up to 168 days
Time of Minimum Serum Concentration of KIVU-107 (Tmin, ss)
PK assessment
Measured: Up to 168 days
Terminal Half-Life (t1/2) of Serum KIVU-107
PK assessment
Measured: 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
Measured: 21 days
Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUCinf) for KIVU-107
PK Assessment
Measured: Up to 168 days
Clearance (CL) of KIVU-107
PK Assessment
Measured: Up to 168 days
Apparent volume of distribution during the terminal phase (Vz) of KIVU-107
PK Assessment
Measured: Up to 168 days
Accumulation ration (Rac) of KIVU-107
PK Assessment
Measured: Up to 168 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study start13 Nov 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advance Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kivu Bioscience Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Louie Naumovski, MD, PhD, Study chair, Kivu Bioscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07229313
- Sponsor's protocol ID
- KIVU-107-01
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose-Finding and Dose-Expansion Study of KIVU-107 in Participants With Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07229313
- Acronym / sponsor ID
- KIVU-107-01
- Conditions
- Advance Solid Tumors
- Keywords
- PTK7, ADC, solid tumors, PTK-7 expression, metastatic, locally advanced, PTK7 expression, endometrial cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Kivu Bioscience Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Nov 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 14 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Finding | Experimental | Drug: KIVU-107Part A: KIVU-107 Dose Finding - Participants will be treated with KIVU-107 in multiple ascending cohorts. |
| Dose Expansion | Experimental | Drug: KIVU-107Part B: KIVU-107 Dose Expansion - Participants will be treated with the RDE from Part A. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female ≥18 years of age
- No therapy of proven efficacy exists for the tumor
- Pathologically or histologically documented diagnosis of advanced / metastatic solid tumor malignancy that is resistant to standard therapy or for which no standard therapy is available.
- Adequate bone marrow, kidney, and liver function
- Measurable disease using RECIST v1.1
Key exclusion criteria (6 listed)
- Prior treatment with any ADC with topoisomerase 1 inhibitor payload
- Any PTK7 - targeted therapy
- Uncontrolled cardiovascular disease
- Active Hepatitis B, Hepatitis C, or HIV infection
- History of interstitial lung disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KIVU-107KIVU-107 will be administered IV. | Drug | Dose Expansion, Dose Finding |
Primary outcome
Part A (Dose Finding): To determine the Maximum Tolerated Dose (MTD)
Time frame: Up to 18 months
Number of participants with treatment emergent adverse events
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
Time frame: Up to 30 months
Number of participants with treatment related adverse events as assessed by CTCAE v5.0
16 secondary outcomes
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 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)
Time frame: 21 days
Maximum serum concentration of KIVU-107 (Cmin)
Time frame: 21 days
Maximum Serum concentration of KIVU-107 at Steady State (Cmax, ss)
Time frame: up to 168 days
Minimum Serum Concentration of KIVU-107 at Steady State (Cmin, ss)
Time frame: up to 168 days
Time of Maximum Serum Concentration of KIVU-107 (Tmax)
Time frame: up to 168 days
Time of Minimum Serum Concentration of KIVU-107 (Tmin)
Time frame: up to 168 days
Time of Minimum Serum Concentration of KIVU-107 (Tmin, ss)
Time frame: Up to 168 days
Terminal Half-Life (t1/2) of Serum KIVU-107
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
Time frame: 21 days
Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUCinf) for KIVU-107
Time frame: Up to 168 days
Clearance (CL) of KIVU-107
Time frame: Up to 168 days
Apparent volume of distribution during the terminal phase (Vz) of KIVU-107
Time frame: Up to 168 days
Accumulation ration (Rac) of KIVU-107
Time frame: Up to 168 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: 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.
Related trials for Advance Solid Tumors
RecruitingObservational study
Collection of Research Data and Samples From Patients Treated With Immunotherapy to Study Its Side Effects
Hematopoietic and Lymphoid Cell Neoplasm, Immune System Disorder
RecruitingPhase 1
Multi Tumor-Associated Antigen-Specific T Lymphocytes to Treat Patients With High Risk Solid Tumors
Solid Tumor
RecruitingPhase 1/2
Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
Liposarcoma, Prostate Cancer
RecruitingPhase 1/2
Study of JMBI-001 in Patients With MYC-Positive Advanced Cancers
Advance Solid Tumors, Lymphoma, Non-Hodgkin
Recruiting
Telephone-Based Coaching Sessions (TAC) to Improve Advance Care Planning Participation in Advanced Cancer Patients and Their Support Person
Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphatic System Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Louie Naumovski, MD, PhD study chair
Kivu Bioscience
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KIVU-107 in people with Advance Solid Tumors, run by Kivu Bioscience Inc. at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kivu Bioscience (US) (+1.650.606.5170, KIVU10701@kivubioscience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A (Dose Finding): To determine the Maximum Tolerated Dose (MTD) (time frame: Up to 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.