Advance Solid Tumors
Conditions
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
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.
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.
Interventions
DRUGKIVU-107
KIVU-107 will be administered IV.
Sponsors
Kivu Bioscience Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part A (Dose Finding): To determine the Maximum Tolerated Dose (MTD) | Up to 18 months | Number of participants with treatment emergent adverse events |
| Number of participants with treatment related adverse events as assessed by CTCAE version 5.0 | Up to 18 months | — |
| To evaluate safety and tolerability of KIVU-107 | Up to 30 months | Number of participants with treatment related adverse events as assessed by CTCAE v5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) is percentage of participants with best response of complete response (CR) or partial response (PR) according to RECIST 1.1 | Up to 30 months | — |
| Duration of Response (DOR) | Up to 30 months | Time from CR or PR to objective disease progression or death to any cause |
| To evaluate the immunogenicity as measured by change of anti-drug antibodies in participants treated with KIVU-107 | Up to 30 months | — |
| Maximum Serum concentration of KIVU-107 (Cmax) | 21 days | PK assessment |
| Maximum serum concentration of KIVU-107 (Cmin) | 21 days | PK assessment |
| Maximum Serum concentration of KIVU-107 at Steady State (Cmax, ss) | up to 168 days | PK assessment |
| Minimum Serum Concentration of KIVU-107 at Steady State (Cmin, ss) | up to 168 days | PK assessment |
| Time of Maximum Serum Concentration of KIVU-107 (Tmax) | up to 168 days | PK assessment |
| Time of Minimum Serum Concentration of KIVU-107 (Tmin) | up to 168 days | PK assessment |
| Time of Minimum Serum Concentration of KIVU-107 (Tmin, ss) | Up to 168 days | PK assessment |
| Terminal Half-Life (t1/2) of Serum KIVU-107 | Up to 168 days | PK assessment |
| Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUClast) for KIVU-107 | 21 days | PK Assessment |
| Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUCinf) for KIVU-107 | Up to 168 days | PK Assessment |
| Clearance (CL) of KIVU-107 | Up to 168 days | PK Assessment |
| Apparent volume of distribution during the terminal phase (Vz) of KIVU-107 | Up to 168 days | PK Assessment |
| Accumulation ration (Rac) of KIVU-107 | Up to 168 days | PK Assessment |
Countries
Australia, United States
Contacts
CONTACTKivu Bioscience (US)
CONTACTKivu Bioscience (Australia)
STUDY_CHAIRLouie Naumovski, MD, PhD
Kivu Bioscience
Outcome results
None listed