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A Phase 1/2 Study of GW5282 in Participants With Advanced Solid Tumors

ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDizal Pharmaceuticals

About this trial

This is a phase 1/2, open-label, multicenter study assessing the safety, tolerability, pharmacokinetics and efficacy of GW5282 in participants with locally advanced or metastatic solid tumors. This study comprised of a dose escalation phase to determine the MTD and the RP2D and a dose expansion phase to further explore the safety, PK and efficacy of GW5282.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All participants must provide a signed, dated written informed consent (ICF) prior to any study-specific procedures, sampling, and analysis.

Male and female participants must be ≥18 years of age at the time of signing the ICF.

Eastern Cooperative Oncology Group performance status of 0-1.

Histologically or cytologically confirmed locally advanced or metastatic solid tumors who has failed standard of cares (SoCs).

Disqualifiers

Any unresolved > grade 1 (according to CTCAE version 5.0) adverse event (excluding alopecia, anemia, neutropenia, and thrombocytopenia) prior to the first administration of investigational drug.

Any known active central nervous system metastases and/or carcinomatous meningitis and/or spinal cord compression.

previously treated with GW5282 or other EZH pathway inhibitors.

previously received any cytotoxic chemotherapy, investigational drug, or other anticancer drug (excluding macromolecular drugs) or clinical trial within 7 days or 5 half-lives (whichever is longer) prior to the first administration of the investigational drug.

Trial design

Design model

Single group

Treatments tested in this trial

  • GW5282

    Drug

    Single dose period (only for dose escalation phase): administered one single dose at assigned dose level orally. Repeated does period (for dose escalation phase and dose expansion phase): administered at assigned dose levels and schedules twice daily (BID) orally in 21-day cycles continuously.

  • GW5282

    Drug

    RDFE will be determined by dose escalation phase.

Treatment groups

203 Participants
are divided into 2 treatment groups
Group A: Dose Escalation PhaseExperimental treatment 1 intervention
Group B: Dose Expansion phaseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Dose Limiting Toxicities (DLTs) (Dose Escalation only)

Time frame
Up to 21 days
2

Number of participants with Adverse Events (AEs)

Time frame
Approximately 24 months from first participant enrolled
3

Number of Participants with Serious Adverse Events (SAEs)

Time frame
Approximately 24 months from first participant enrolled
4

Overall Response Rate (ORR)

ORR is defined as the percentage of subjects with Best Response of Complete Response (CR) or Partial Response (PR) as determined by the investigator

Time frame
Approximately 24 months from first participant enrolled

Secondary outcomes

1

Cmax; Maximum Plasma Concentration of GW5282

Time frame
Single dose period (only for dose escalation phase): 0 (predose) up to 72 hours post-dose
2

AUC; Area Under the Plasma Concentration-time Curve of GW5282

Time frame
Single dose period (only for dose escalation phase): 0 (predose) up to 72 hours post-dose
3

Tmax; Time to Reach Maximum Plasma Concentration (Cmax) of GW5282

Time frame
Single dose period (only for dose escalation phase): 0 (predose) up to 72 hours post-dose
4

Css,max; Maximum Steady State Plasma Concentration of GW5282

Time frame
Cycle 1 Day 15: 0 (predose) up to 12 hours post-dose

Other outcomes

Sponsors and contacts

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Dizal Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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