A Study of KIVU-107 in Participants With Locally Advanced or Metastatic Solid Tumors
Purpose
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.
Condition
- Advance Solid Tumors
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Kivu Trial Site
Santa Monica, California 90403
Santa Monica, California 90403
More Details
- Status
- Recruiting
- Sponsor
- Kivu Bioscience Inc.
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.