Health TrialsbyHealthPanel

A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors

ConditionsSolid TumorAdvanced Solid TumorSolid Tumor, AdultMetastatic TumorOvarian CancerOvarian NeoplasmsOvarian CarcinomaMetastatic Ovarian CarcinomaEndometrial NeoplasmsEndometrial DiseasesMetastatic Endometrial CancerTriple Negative Breast CancerMetastatic Endometrial CarcinomaAdvanced Endometrial CarcinomaAdvanced Ovarian CarcinomaGastric CancerAdvanced Gastric CarcinomaMetastatic Gastric CancerMetastatic Gastric CarcinomaSmall Cell Lung CancerSmall Cell Lung CarcinomaTriple Negative Breast NeoplasmsPlatinum-resistant Ovarian CancerPlatinum-refractory Ovarian CarcinomaCCNE1 AmplificationHormone Receptor Negative Breast CarcinomaHuman Epidermal Growth Factor 2 Negative Carcinoma of BreastProgesterone-receptor-positive Breast Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19+
SponsorNiKang Therapeutics, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ovarian cancer

Endometrial cancer (only endometrioid subtype will require CCNE1 amplification)

Gastric, gastroesophageal junction (GEJ) or esophageal adenocarcinoma with CCNE1 amplification

Small cell lung cancer (SCLC)

Disqualifiers

Locally advanced solid tumor that is a candidate for curative treatment through radical surgery and/or radiotherapy, or chemotherapy.

History of another malignancy with exceptions

History of lymphohistiocytic or lymphoid hyperplasia; hemophagocytic lymphohistiocytosis.

Failed to recover from effects of prior anticancer treatment therapy to baseline or Grade ≤ 1 severity (per CTCAE)

Trial design

Design model

Sequential

Treatments tested in this trial

  • NKT3964

    Drug

    Oral CDK2 Degrader

  • Paclitaxel

    Drug

    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

    Drug

    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.

Treatment groups

238 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Group A: Monotherapy Dose Expansion 2AExperimental treatment 1 intervention
Group B: Combination Dose Expansion 4AExperimental treatment 2 interventions
Group C: Combination Dose Expansion 4BExperimental treatment 2 interventions
Group D: Monotherapy Dose Expansion 2BExperimental treatment 1 intervention
Group E: Monotherapy Dose Expansion 2CExperimental treatment 1 intervention
Group F: Monotherapy Dose Expansion 2DExperimental treatment 1 intervention
Group G: Monotherapy Dose Expansion 2EExperimental treatment 1 intervention
Group H: Monotherapy Dose EscalationExperimental treatment 1 intervention
Group I: Combination Dose Escalation 3AExperimental treatment 2 interventions
Group J: Combination Dose Escalation 3BExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of Participants with Dose Limiting Toxicity (DLT) events

DLTs graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0

Time frame
28 Days
2

Objective Response Rate (ORR)

ORR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as determined by the Investigator

Time frame
1 Year

Secondary outcomes

1

Progression-free survival (PFS)

PFS defined as the time from the date the participant started study drug to the date the participant experiences an event of disease progression or death.

Time frame
2 Year
2

Duration of Response (DOR)

Duration of overall response is defined as the time from the date of first confirmed CR or PR, assessed by investigator and based on RECIST v. 1.1, to the documented date of progressive disease (PD) including clinical progression, or death due to any cause, or the start of subsequent anticancer therapy, whichever occurred first.

Time frame
2 Year
3

Disease control rate

Disease control rate defined as CR + PR + stable disease \[SD\] for at least 8 weeks

Time frame
1 Year
4

Overall Survival (OS)

OS defined as the time from the date the participant started study drug to death for any reason.

Time frame
2 Year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NiKang Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
Apply now