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

Conditions

• CCNE1 Amplified Advanced Solid Tumors
• HR+ Breast Cancer
• HR+ HER2- Breast Cancer
• Triple Negative Breast Cancer (TNBC)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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

Key Dates

First listed

Jun 19, 2025

Start date

Mar 25, 2025

Status verified

Jun 2026

Primary completion

Jul 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

361 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Part 1 Dose Escalation
  Escalation of orally administered NKT5097
• Experimental: Part 2 Food Effect
  Orally administered NKT5097 with and without meal
• Experimental: Part 3 Expansion
  Expansion of dose levels based upon safety and PK following Part 1 escalation.
• Experimental: Part 4 Combination Dose Escalation
  Escalation of orally administered NKT5097 in combination with Endocrine Therapy (ET)
• Experimental: Part 5 Combination Expansion
  Expansion of dose levels based upon safety and PK following Part 4 escalation

Primary Outcome Measure

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 ]

Central Contacts

• Sponsor Contact
  302-596-8654
  [email protected]

Locations (18)

Find similar trials in Duarte, CA

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