A Study of KIVU-107 in Participants With Locally Advanced or Metastatic Solid Tumors

Kivu Bioscience Inc.

Status and phase: Enrolling; Phase 1

Conditions: Advance Solid Tumors

Treatments: Drug: KIVU-107

Study type: Interventional

Funder types: Industry

Identifiers

NCT07229313

KIVU-107-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

Dose Finding

Experimental group

Description:

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

Treatment:

Drug: KIVU-107

Dose Expansion

Experimental group

Description:

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

Treatment:

Drug: KIVU-107