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

ConditionsSolid Tumor MalignanciesColorectal CarcinomaSmall Cell Lung Cancer ( SCLC )Head and Neck (HNSCC)Bladder CancerNon-Small Cell Lung CancerPancreatic Cancer, Advanced or Metastatic
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTasca Therapeutics

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Measurable or non measurable cancer that the research can assess for changes

Not eligible or able to take existing standard therapies for cancer

Availability of a part of a tumor for laboratory testing or willing to have a safe biopsy taken from a tumor

Diagnosed with locally advanced, recurrent or metastatic incurable disease

Disqualifiers

Inability to swallow pills

Known history of HIV, HCV, HBV unless cured, controlled with undetectable viral load

Active tumor in the brain

Clinically significant liver disease

Trial design

Design model

Sequential

Treatments tested in this trial

  • CP-383

    Drug

    Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells

Treatment groups

150 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Group A: Dose Level 1Experimental treatment 1 intervention
Group B: Dose Level 2Experimental treatment 1 intervention
Group C: Dose Level 3Experimental treatment 1 intervention
Group D: Dose Level 4Experimental treatment 1 intervention
Group E: Dose Level 5Experimental treatment 1 intervention
Group F: Dose Level 6Experimental treatment 1 intervention
Group G: Expansion Arm 1Experimental treatment 1 intervention
Group H: Expansion Arm 2Experimental treatment 1 intervention
Group I: Expansion Arm 3Experimental treatment 1 intervention
Group J: Expansion Arm 4Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part 1: Determine the maximum tolerated dose (MTD)

Determine the MTD of CP-383 in subjects with advanced solid tumors

Time frame
21 days
2

Part 2: Evaluate the efficacy of CP-383 at the recommended phase 2 dose in selected tumor types

Objective response rate assessed by the investigator according to RECIST

Time frame
From enrollment through study completion, an average of 1 year

Secondary outcomes

1

Part 1: Determine the pharmacokinetics parameters of CP-383

Assess standard PK parameters including Cmax

Time frame
From enrollment through study completion, an average of 1 year
2

Part 1: Determine the pharmacokinetics parameters of CP-383

Assess standard PK parameters including tmax

Time frame
From enrollment through study completion, an average of 1 year
3

Part 1: Determine the pharmacokinetics parameters of CP-383

Assess standard PK parameters including AUC

Time frame
From enrollment through study completion, an average of 1 year
4

Part 1: Assess safety and tolerability of CP-383 in participants with advanced solid tumors

Incidence and severity of Adverse events and changes in test results

Time frame
From enrollment through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

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

Tasca Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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