Status and phase
Conditions
Treatments
About
The goal of the Dose Escalation phase of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity to determine the preliminary recommended dose for expansion (RDE) of NKT3964 in adults with advanced or metastatic solid tumors. The goal of the Expansion phase of the study is to evaluate the preliminary anti-tumor activity of NKT3964 at the RDEs based on objective response rate (ORR) and determine the preliminary recommended Phase 2 dose (RP2D).
Full description
Inclusion Criteria:
Dose Escalation:
Dose Expansion:
Part 2A: Pathologically confirmed HR+ and HER2- breast cancer which must have progressed following treatment with a CDK4/6 inhibitor, are not suitable for further endocrine therapy and have had no more than one line of prior systemic chemotherapy in the metastatic setting.
Part 2B: Platinum resistant or refractory ovarian cancer (defined as recurrence ≤6 months after completing platinum-based regimen) with progression on at least one platinum containing therapy, with CCNE1 amplification as determined by NGS by local liquid or tissue test.
Part 2C: Advanced unresectable or metastatic gastric, GEJ or esophageal adenocarcinoma with progression on at least one systemic therapy, with CCNE1 amplification as determined by NGS by local liquid or tissue test.
Exclusion Criteria:
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Dose Escalation:
Dose Expansion:
Part 2A: Pathologically confirmed HR+ and HER2- breast cancer which must have progressed following treatment with a CDK4/6 inhibitor, are not suitable for further endocrine therapy and have had no more than one line of prior systemic chemotherapy in the metastatic setting.
Part 2B: Platinum resistant or refractory ovarian cancer (defined as recurrence ≤6 months after completing platinum-based regimen) with progression on at least one platinum containing therapy, with CCNE1 amplification as determined by NGS by local liquid or tissue test.
Part 2C: Advanced unresectable or metastatic gastric, GEJ or esophageal adenocarcinoma with progression on at least one systemic therapy, with CCNE1 amplification as determined by NGS by local liquid or tissue test.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
90 participants in 2 patient groups
Loading...
Central trial contact
Sponsor Contact
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal