Health TrialsbyHealthPanel

REC-7735 in Participants With Solid Tumors

ConditionSolid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRecursion Pharmaceuticals Inc.

About this trial

The study is designed to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of REC-7735 in participants with unresectable, locally advanced, or metastatic PIK3CA-H1047R mutated solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants have histologically-confirmed unresectable, locally advanced, or metastatic solid tumors which exhibit the PIK3CA H1047R mutation in tumor tissue and/or blood (circulating tumor deoxyribonucleic acid [ctDNA]).

For Phase 1A and planned monotherapy cohorts in Phase 1B, participants have experienced progressive disease, relapsed disease, or be intolerant to at least one established standard systemic anti-cancer treatment for a given tumor type, or in the opinion of the Investigator have been considered ineligible for standard therapy.

All toxicities from prior anti-cancer therapies have resolved to ≤ Grade 1 or the participant's previous baseline, with the exception of alopecia and peripheral neuropathy.

Disqualifiers

Participants have experienced disease progression with a phosphoinositide 3-kinase (PI3Ka), protein kinase B (AKT) or mechanistic target of rapamycin (mTOR) inhibitor unless deemed suitable for REC-7735 treatment at the discretion of the Investigator and following discussion with the Sponsor.

Known loss-of-function mutations in phosphatase and tensin homolog (PTEN), PTEN loss, or activating mutations in AKT, unless deemed suitable for REC-7735 treatment at the discretion of the Investigator and following discussion with the Sponsor.

Major surgery within 6 weeks from treatment initiation.

Any serious underlying medical or psychiatric condition that would preclude understanding and rendering of informed consent or impair the ability of the participant to receive or tolerate the planned treatment.

Trial design

Design model

Sequential

Treatments tested in this trial

  • REC-7735

    Drug

    Oral

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Phase 1A Dose Finding: REC-7735Experimental treatment 1 intervention
Group B: Phase 1B Dose Expansion/Optimization: REC-7735Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Phase 1A: Number of Participants With Dose-limiting Toxicities (DLTs)

Time frame
28 days
2

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Time frame
Up to 2 years
3

Phase 1B: Objective Response Rate (ORR) According to Standard Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Time frame
Up to 2 years

Secondary outcomes

1

Maximum (Peak) Drug Concentration (Cmax) of REC-7735

Time frame
Up to 2 years
2

Time to Reach Cmax following drug administration (Tmax) of REC-7735

Time frame
Up to 2 years
3

Area Under the Concentration-time Curve During a Dosing Interval (AUCtau) of REC-7735

Time frame
Up to 2 years
4

Phase 1A: ORR According to Standard RECIST 1.1

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

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

Recursion Pharmaceuticals Inc.

Lead sponsor

Source ClinicalTrials.gov
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