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

Part of paid clinical trials in Santa Monica, California.

Sponsor
Kivu Bioscience Inc.
Study ID
NCT07229313
Phase
PHASE1
Status
Recruiting

Conditions

  • Advance Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • KIVU-107 — DRUG
    KIVU-107 will be administered IV.

Study Details

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.

Key Dates

Start date
Nov 13, 2025
Status verified
Apr 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2030

Study Design

Enrollment
76 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Part A (Dose Finding): To determine the Maximum Tolerated Dose (MTD) [ Time Frame: Up to 18 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Kivu Trial SiteSanta MonicaCalifornia90403-

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