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A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors

ConditionsHR+ Breast CancerTriple Negative Breast Cancer (TNBC)CCNE1 Amplified Advanced Solid TumorsHR+ HER2- Breast Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNiKang Therapeutics, Inc.

About this trial

The goal of this open-label dose escalation and expansion study is to evaluate the safety and tolerability of NKT5097 in adults with advanced/metastatic tumors (emphasis on breast cancer and solid tumors with CCNE1 amplification). Main questions to answer include:

* What is the recommended dose for expansion and/or Phase 2, for both monotherapy and in combination with ET * What medical issues/symptoms do participants experience when taking NKT5097 as monotherapy as well as in combination with ET

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able to provide written informed consent

Advanced unresectable or metastatic solid tumor (Part 1, 2 & 3 only)

Advanced unresectable or metastatic HR+/HER2- breast cancer (Part 4 & 5 only)

Refractory to or unable to tolerate existing therapies (Part 1, 2 & 4 only)

Disqualifiers

Advanced solid tumor that is a candidate for curative treatment

History of another malignancy except for the following: adequately treated local basal cell or squamous carcinoma of the skin, in situ cervical cancer, adequately treated papillary noninvasive bladder cancer, other adequately treated Stage I or Stage II cancers currently in complete remission

Not recovered from the effects of prior anticancer therapy

Clinically significant cardiovascular event, including myocardial infarction, arterial thromboembolism, or cerebrovascular thromboembolism, within 6 months

Trial design

Design model

Single group

Treatments tested in this trial

  • NKT5097 CDK2/CDK4 dual degrader

    Drug

    NKT5097 will be distributed in tablet form and dosed daily or twice a day

  • Fulvestrant

    Drug

    Fulvestrant will be administered as an injection and dosed on C1D1, C1D15 and Day 1 of every cycle thereafter.

  • Letrozole

    Drug

    Letrozole will be administered orally once daily.

Treatment groups

361 Participants
are divided into 5 treatment groups
Group A: Part 1 Dose EscalationExperimental treatment 1 intervention
Group B: Part 2 Food EffectExperimental treatment 1 intervention
Group C: Part 3 ExpansionExperimental treatment 1 intervention
Group D: Part 4 Combination Dose EscalationExperimental treatment 3 interventions
Group E: Part 5 Combination ExpansionExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Incidence of dose-limiting toxicities as Assessed by CTCAE

Time frame
From enrollment through end of safety monitoring period of 28 days from first dose

Secondary outcomes

1

Incidence of adverse events (AEs) as defined by CTCAE Version 5

Time frame
From enrollment through end of treatment up to 2 years
2

Maximum concentration Cmax after a single dose and multiple doses

Time frame
Day 1 and Day 15 of Cycle 1 (Cycle 1 is 28 days)
3

Area under the concentration-time curve (AUC last) after a single dose and multiple doses from first dose through the last timepoint with quantifiable concentration (Tlast)

Time frame
Day 1 and Day 15 of Cycle 1 ((Cycle 1 is 28 days)
4

Maximum concentration (Cmax) when dosed with and without food

Time frame
Day 1 and Day 2 of Cycle 1 (Cycle 1 is 28 days)

Other outcomes

Sponsors and contacts

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

NiKang Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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