Study of CP-383 in Patients With Advanced or Metastatic Solid Tumors

Conditions

• Bladder Cancer
• Colorectal Carcinoma
• Head and Neck (HNSCC)
• Non-Small Cell Lung Cancer
• Pancreatic Cancer, Advanced or Metastatic
• Small Cell Lung Cancer ( SCLC )
• Solid Tumor Malignancies

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• CP-383 — DRUG
  Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells

Study Details

The goal of this clinical trial is to learn if an investigational drug CP-383 works to treat advanced cancer. It will also learn about the safety of CP-383. The main questions if aims to answer are: * Does CP-383 slow or stop the growth of cancer in patients with advanced cancer * What medical problems do participants have when taking CP-383 Researchers will test CP-383 in all kinds of cancers at various dose levels to determine what the best dose is to study further. Researchers will also see if certain cancers that have gene mutations respond better to CP-383 Participants will: * Take CP-383 every day by mouth until the researcher learns whether CP-383 is helping slow or reduce the cancer growth * Visit the clinic weekly for the first 6 weeks for checkups and tests * Visit the clinic every 3 weeks thereafter for checkups and tests

Key Dates

Start date

Aug 27, 2025

Status verified

Jan 2026

Primary completion

Aug 15, 2028

Completion

Feb 28, 2029

Study Design

Enrollment

150 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Dose Level 1
  CP-383, single daily oral capsule, 0.8 mg
• Experimental: Dose Level 2
  CP-383, single daily oral capsule, 1.6 mg
• Experimental: Dose Level 3
  CP-383, single daily oral capsule, 3.0 mg
• Experimental: Dose Level 4
  CP-383, single daily oral capsule, 5.0 mg
• Experimental: Dose Level 5
  CP-383, single daily oral capsule, 8.0 mg
• Experimental: Dose Level 6
  CP-383, single daily oral capsule, 12 mg
• Experimental: Expansion Arm 1
  Expansion in selected tumor type at recommended Phase 2 Dose of CP-383
• Experimental: Expansion Arm 2
  Expansion in selected tumor type at recommended Phase 2 Dose of CP-383
• Experimental: Expansion Arm 3
  Expansion in selected tumor type at recommended Phase 2 Dose of CP-383
• Experimental: Expansion Arm 4
  Expansion in selected tumor type at recommended Phase 2 Dose of CP-383

Primary Outcome Measure

Part 1: Determine the maximum tolerated dose (MTD) [ Time Frame: 21 days ]

Central Contacts

• Tasca Therapeutics
  617-430-7109
  [email protected]

Locations (13)

Find similar trials in Denver, CO

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