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

ConditionAdvance Solid Tumors

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorKivu Bioscience Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

KIVU-107
Drug
KIVU-107 will be administered IV.

Treatment groups

76 Participants

are divided into 2 treatment groups

Group A: Dose FindingExperimental treatment 1 intervention

Group B: Dose ExpansionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Part A (Dose Finding): To determine the Maximum Tolerated Dose (MTD)

Number of participants with treatment emergent adverse events

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

Number of participants with treatment related adverse events as assessed by CTCAE v5.0

Time frame

Up to 30 months

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 from CR or PR to objective disease progression or death to any cause

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)

PK assessment

Time frame

21 days

Other outcomes

To evaluate biomarkers with potential to predict response and/or resistance to KIVU-107 characterize baseline levels and/ or changes in genomic, mRNA and/or protein biomarkers to determine any signatures correlated with response or resistance.

Time frame

Up to 30 months

Progression Free Survival (PFS) is defined as the time from the first dose to either disease progression according to RECIST v. 1.1, or death due to any cause, whichever comes first.

Time frame

Up to 30 months

Overall Survival (OS)

Proportion of participants alive at 1 year from the start of treatment to death from any cause

Time frame

Up to 30 months

Time to Response (TTR)

Time from start of treatment to complete response or partial response

Time frame

Up to 30 months