Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors
Recruiting
Phase 1
Interventional Study
Breast Cancer
Ovarian Cancer
Endometrial Cancer
PIK3CA Mutation
HER2- Negative Breast Cancer
Advanced Breast Cancer
Unresectable Solid Tumor
Hormone Receptor Positive Tumor
Cervical Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 63 (estimated)
- Sponsor
- Regor Pharmaceuticals Inc. · Industry
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About This Trial
This is a phase 1/1b, open-label, multicenter study consisting of sequential parts designed to evaluate the safety, tolerability, and effects pharmacokinetic (PK) profile, and antitumor activity of RGT-490, an investigational oral therapy, in adults with locally advanced or metastatic solid tumors including breast cancer.
Participants enrolled in the study have advanced disease that is not amenda…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Adults with metastatic or locally advanced, unresectable solid tumors that have progressed on or after at least one available therapy.
* Presence of one or more documented activating PIK3CA mutation in tumor tissue and/or blood.
* At least 1 measurable lesion or evaluable dise…
Contacts