NiKang Therapeutics, Inc.
The goal of the Monotherapy Dose Escalation phase (Part 1) 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 Monotherapy Expansion phase of the study (Part 2) is to evaluate the preliminary anti-tumor activity of NKT3964 at the RDE based on objective response rate (ORR) and determine the preliminary recommended Phase 2 dose (RP2D). The goal of the Combination Dose Escalation phase (Part 3) of the study is to identify the RDE of NKT3964 in combination with chemotherapy in adult subjects with advanced/metastatic endometrial cancer. The goal of the Combination Expansion phase of the study (Part 4) is to evaluate the preliminary anti-tumor activity of NKT3964 in combination with chemotherapy at the RDE based on ORR.
Inclusion Criteria: \- Must have a pathologically confirmed, advanced and unresectable or metastatic solid tumor listed below with documented disease progression on last standard treatment. For Part 1 Monotherapy Dose Escalation (including Food Effect Sub-study): Patients must be refractory to, or intolerant of existing therapy(ies) known to provide clinical benefit for their condition. Part 1 Monotherapy Dose Escalation and Food Effect Sub-study: 1. Ovarian cancer 2. Endometrial cancer (only 'endometrioid' subtype requires CCNE1 amplification) 3. Gastric, gastroesophageal junction (GEJ) o…
Inclusion Criteria: \- Must have a pathologically confirmed advanced and unresectable or metastatic solid tumor listed below with documented disease progression on last standard treatment. Part 1 Monotherapy Dose Escalation (including Food Effect Sub-study): subjects must be refractory to, or intolerant of existing therapy(ies) known to provide clinical benefit for their condition. Part 1 Monotherapy Dose Escalation: 1. Ovarian cancer 2. Endometrial cancer (only endometrioid subtype will require CCNE1 amplification) 3. Gastric, gastroesophageal junction (GEJ) or esophageal adenocarcinoma wi…
Oral CDK2 Degrader
Paclitaxel will be administered on a 3 weeks on, 1 week off schedule at a dose of 80 mg/m2 IV. Subjects will receive a total of 6 cycles of paclitaxel.
Doxorubicin will be administered every 3 weeks at a dose of 60 mg/m2 IV. Subjects will receive a total of 6 cycles of doxorubicin.