Recruiting
Phase 1

KIVU-107

Sponsor:

Kivu Bioscience Inc.

Code:

NCT07229313

Conditions

Advance Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

KIVU-107

Study Details

Brief 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.

Conditions

Advance Solid Tumors

Study ID

NCT07229313

Start date

Nov 13, 2025

Status verified date

Sep, 2026

Completion date

Mar 31, 2030

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

76 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Finding

Part A: KIVU-107 Dose Finding - Participants will be treated with KIVU-107 in multiple ascending cohorts.

experimental: Dose Expansion

Part B: KIVU-107 Dose Expansion - Participants will be treated with the RDE from Part A.

Interventions

KIVU-107

KIVU-107 will be administered IV.

Primary outcome measure

  • Part A (Dose Finding): To determine the Maximum Tolerated Dose (MTD) [ 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 [ Time Frame: Up to 30 months ]

Central Contacts and Locations

Central contacts

Kivu Bioscience (US)

+1.650.606.5170KIVU10701@kivubioscience.com

Kivu Bioscience (Australia)

+61 8 7223 0122KIVU10701@kivubioscience.com

Locations

Kivu Trial Site

Recruiting

Santa Monica, California, United States, 90403

Kivu Trial Site

Recruiting

New Have, Connecticut, United States, 06520

More Information

Sponsor

Kivu Bioscience Inc.

Last update posted

Sep 24, 2026

Last verified

Sep, 2026

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
  • NSCLC
  • SCLC
  • CRC
  • PDAC
  • HNSCC
  • TNBC
  • triple negative breast cancer
  • antibody drug conjugate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Kivu Bioscience Inc. on 2026-09-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.