Phase 1: Dose Escalation for HPV-Related Squamous Cell Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of California, San Francisco, San Francisco, CA
HPV-Related Squamous Cell Carcinoma+10 More
Hyperpolarized Carbon-13 (13C) Pyruvate - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This phase I/II trial tests the safety, side effects, and best dose of alpelisib and whether alpelisib and carboplatin work to shrink tumors in patients with solid tumors or human papillomavirus (HPV) positive squamous cell carcinoma that has spread to nearby tissue or lymph nodes (locally advanced) or has spread to other places in the body (metastatic). Alpelisib belongs to a group of medicines called phosphatidylinositol 3-kinase (PI3K) inhibitors. This means alpelisib blocks the activity of the PI3K protein. The PI3K pathway is well known to be involved in tumor cell multiplication and survival. Blocking PI3K may reduce the ability of certain cancers to grow. Carboplatin is an anticancer drug or chemotherapy drug that binds to DNA causing damage that prevents the DNA from replicating, which prevents the cells itself from reproducing. Giving alpelisib and carboplatin may help control the disease in patients with solid tumors and HPV positive squamous cell carcinoma.

Eligible Conditions

  • HPV-Related Squamous Cell Carcinoma
  • Locally Advanced Malignant Solid Neoplasm
  • Metastatic Malignant Solid Neoplasm
  • Human Papilloma Virus-Related Carcinoma
  • PIK3CA Mutation
  • Human Papillomavirus-Related Squamous Cell Carcinoma
  • Solid Tumors, Adult
  • PIK3CA Mutation-Related Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

5 Primary · 2 Secondary · Reporting Duration: Up to 3 years

Day 21
Maximum Tolerated Dose (MTD) (Phase 1)
Percentage of participant with reported DLT (Phase 1)
Recommended Phase 2 Dose (Phase 1)
Up to 3 years
Median progression-free survival (Phase 2)
Overall Response Rate Phase (Phase 2)
Percentage of participants with treatment-related adverse events
Proportion of participants with abnormal glucose values over time

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Phase 1: Dose Escalation
1 of 2
Phase 2: Dose Expansion
1 of 2
Experimental Treatment

55 Total Participants · 2 Treatment Groups

Primary Treatment: Phase 1: Dose Escalation · No Placebo Group · Phase 1

Phase 1: Dose EscalationExperimental Group · 4 Interventions: Hyperpolarized Carbon-13 (13C) Pyruvate, Continuous Glucose Monitor (CGM), Alpelisib, Carboplatin · Intervention Types: Drug, Device, Drug, Drug
Phase 2: Dose ExpansionExperimental Group · 4 Interventions: Hyperpolarized Carbon-13 (13C) Pyruvate, Continuous Glucose Monitor (CGM), Alpelisib, Carboplatin · Intervention Types: Drug, Device, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Continuous Glucose Monitor (CGM)
2017
Completed Phase 3
~600
Alpelisib
2015
Completed Phase 1
~30
Carboplatin
2014
Completed Phase 3
~6570

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years
Closest Location: University of California, San Francisco · San Francisco, CA
Photo of San Francisco  1Photo of San Francisco  2Photo of San Francisco  3
2008First Recorded Clinical Trial
1 TrialsResearching HPV-Related Squamous Cell Carcinoma
688 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Patients may have received any number of lines of prior systemic therapy for locally advanced/metastatic disease.
You have a dose escalation.
You have a locally advanced or metastatic solid tumor malignancy with no curative treatment options available.
Patients will be informed of alternative therapies known to confer clinical benefit.
A positive HPV test result for any of the following HPV types (16, 18, 31, 33, 35, 39, 45, 51, 56, 58, 59, 66, or 68) in a patient with a diagnosis of anogenital warts or condylomata acuminata (warty genital lesions) or cervical intraepithelial neoplasia (CIN) 2 or 3, or both, will be sufficient to establish eligibility for the vaccine.
You have radiographic or clinical evidence of platinum resistance.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.