Serabelisib for PTEN Loss of Function Mutation

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
PTEN Loss of Function Mutation+2 MoreSerabelisib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial will study if a drug combo is safe and effective with the goal of reducing side effects.

Eligible Conditions
  • Advanced Solid Tumors
  • PIK3CA Gene Mutation
  • PTEN Loss of Function Mutation

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

11 Primary · 23 Secondary · Reporting Duration: Through study completion, up to 12 months.

Month 8
Cohort 1: Antitumor efficacy of serabelisib in combination with a Study ISD by measuring DCR.
Cohort 1: Antitumor efficacy of serabelisib in combination with a Study ISD by measuring DoR.
Cohort 1: Antitumor efficacy of serabelisib in combination with a Study ISD by measuring ORR.
Cohort 1: Antitumor efficacy of serabelisib in combination with a Study ISD by measuring OS.
Cohort 1: Antitumor efficacy of serabelisib in combination with a Study ISD by measuring PFS.
Cohort 1: Evaluate the compliance of instrasubject modulated dosing for serabelisib in combination with a Study ISD in a pilot cohort.
Cohort 1: Evaluate the pharmacokinetic impact of instrasubject modulated dosing for serabelisib in combination with a Study ISD in a pilot cohort by measuring AUC.
Cohort 1: Evaluate the pharmacokinetic impact of instrasubject modulated dosing for serabelisib in combination with a Study ISD in a pilot cohort by measuring Cmax.
Cohort 1: Evaluate the pharmacokinetic impact of instrasubject modulated dosing for serabelisib in combination with a Study ISD in a pilot cohort by measuring Tmax.
Cohort 1: Evaluate the safety of instrasubject modulated dosing for serabelisib in combination with a Study ISD in a pilot cohort.
Cohort 2, 3, 4: Additional assessments of antitumor efficacy of serabelisib in combination with a Study ISD (Measuring DCR).
Cohort 2, 3, 4: Additional assessments of antitumor efficacy of serabelisib in combination with a Study ISD (Measuring DoR).
Cohort 2, 3, 4: Additional assessments of antitumor efficacy of serabelisib in combination with a Study ISD (Measuring OS).
Cohort 2, 3, 4: Additional assessments of antitumor efficacy of serabelisib in combination with a Study ISD (Measuring PFS).
Cohort 2, 3, 4: Confirm the compliance of serabelisib in combination with a Study ISD.
Cohort 2, 3, 4: Confirm the safety of serabelisib in combination with a Study ISD.
Cohorts 2, 3, 4: Use the Objective Response Rate (ORR) to assess the antitumor efficacy of serabelisib in combination with a Study ISD.
Month 12
Cohort 2, 3, 4: Additional assessments of antitumor efficacy of study intervention (Measuring DCR).
Cohort 2, 3, 4: Additional assessments of antitumor efficacy of study intervention (Measuring DoR).
Cohort 2, 3, 4: Additional assessments of antitumor efficacy of study intervention (Measuring OS).
Cohort 2, 3, 4: Additional assessments of antitumor efficacy of study intervention (Measuring PFS).
Cohort 2, 3, 4: Assess the population PK and intra-tumoral concentration of study intervention.
Cohort 2, 3, 4: Confirm safety
Cohort 2, 3, 4: Confirm the compliance of study intervention.
Cohorts 1a/1b, 2, 3, 4: Assessment of PD of study intervention.
Cohorts 1a/1b, 2, 3, 4: Assessment of genetic predictors of efficacy.
Cohorts 1a/1b, 2, 3, 4: Assessment of genetic predictors of toxicity.
Cohorts 1a/1b, 2, 3, 4: Assessment of immune markers in response to study intervention.
Dacryocystorhinostomy
Cohorts 1a/1b: Antitumor efficacy of study intervention by measuring DoR.
Cohorts 1a/1b: Antitumor efficacy of study intervention by measuring ORR.
Cohorts 1a/1b: Antitumor efficacy of study intervention by measuring OS.
Cohorts 1a/1b: Antitumor efficacy of study intervention by measuring PFS.
Cohorts 1a/1b: Evaluate compliance
Cohorts 1a/1b: Evaluate safety
Impacted tooth
Cohorts 1a/1b: Evaluate the pharmacokinetic impact by measuring Cmax.
Cohorts 1a/1b: Evaluate the pharmacokinetic impact by measuring Tmax.

Trial Safety

Safety Progress

1 of 3

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Trial Design

6 Treatment Groups

Cohort 4 - Expansion Ovarian Clear Cell or Ovarian Endometrioid Carcinoma
1 of 6
Cohort 1a - Dose Modification without nab-paclitaxel
1 of 6
Cohort 1b - Dose Modification with Nab-Paclitaxel
1 of 6
Cohort 1 - Dose Modification
1 of 6
Cohort 3 - Expansion Endometrial Cancer
1 of 6
Cohort 2 - Expansion Colorectal Cancer
1 of 6

Experimental Treatment

68 Total Participants · 6 Treatment Groups

Primary Treatment: Serabelisib · No Placebo Group · Phase 1

Cohort 4 - Expansion Ovarian Clear Cell or Ovarian Endometrioid CarcinomaExperimental Group · 3 Interventions: Insulin Suppressing Diet, Nab paclitaxel, Serabelisib · Intervention Types: Other, Drug, Drug
Cohort 1a - Dose Modification without nab-paclitaxelExperimental Group · 2 Interventions: Insulin Suppressing Diet, Serabelisib · Intervention Types: Other, Drug
Cohort 1b - Dose Modification with Nab-PaclitaxelExperimental Group · 3 Interventions: Insulin Suppressing Diet, Nab paclitaxel, Serabelisib · Intervention Types: Other, Drug, Drug
Cohort 1 - Dose ModificationExperimental Group · 2 Interventions: Insulin Suppressing Diet, Serabelisib · Intervention Types: Other, Drug
Cohort 3 - Expansion Endometrial CancerExperimental Group · 3 Interventions: Insulin Suppressing Diet, Nab paclitaxel, Serabelisib · Intervention Types: Other, Drug, Drug
Cohort 2 - Expansion Colorectal CancerExperimental Group · 2 Interventions: Insulin Suppressing Diet, Serabelisib · Intervention Types: Other, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, up to 12 months.

Who is running the clinical trial?

Faeth TherapeuticsLead Sponsor
2 Previous Clinical Trials
120 Total Patients Enrolled
Vicky MakkerPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
28 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have either a solid tumor or an ovarian cancer with ≥ 50% clear cell histology or ovarian clear cell or ovarian endometrioid carcinoma.
You have a primary ovarian carcinoma.
Cohort 1b - Dose Modification (subjects with solid tumor): failed, were intolerant of, or ineligible for no more than 3 prior lines of therapy (LOT) for advanced/metastatic disease or refused SOC therapy.