An Open-label, Phase 1a/1b, Dose Escalation and Dose Expansion Study Investigating the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of PHST001 in Adult Patients With Advanced Relapsed and/or Refractory Solid Tumors
Status: Recruiting
Location: See all (20) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
This is a multi-center, first-in-human (FIH), open-label, Phase 1a/1b dose escalation and dose expansion study to assess the safety, PK, pharmacodynamics, and antitumor activity of PHST001 monotherapy (Phase 1a) or in combination with chemotherapy (Phase 1b) in adult participants with advanced relapsed and/or refractory solid tumors (including but not limited to CNS tumors in Phase 1a only). In Phase 1b cohort expansions, the study will focus on participants with advanced relapsed and/or refractory ovarian cancer, endometrial cancer, and cholangiocarcinoma. The study's primary objective is to evaluate the safety and tolerability of PHST001 and determine the RP2D (Recommended Phase 2 dose) of PHST001 monotherapy and in combination with chemotherapy as well as assess the anti-tumor activity of PHST001 and chemotherapy in Phase 1b.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Histologically or cytologically confirmed advanced solid tumor which has relapsed from or been refractory to all locally available standard therapies.
• Adequate organ function per laboratory testing
• Pregnancy prevention requirements
• Measurable disease per RECIST v1.1 (or RANO) as assessed by the local site Investigator/radiology
• Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
Locations
United States
California
Precision NextGen Oncology & Research Center
NOT_YET_RECRUITING
Beverly Hills
USC Norris Comprehensive Cancer Center
RECRUITING
Los Angeles
Stanford University School of Medicine
RECRUITING
Palo Alto
Colorado
Sarah Cannon Research Institute (SCRI) Oncology Partners - Denver Health One
RECRUITING
Denver
Connecticut
Yale Cancer Center
RECRUITING
New Haven
Illinois
University of Chicago Medical Center
RECRUITING
Chicago
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
Michigan
University of Michigan Rogel Cancer Center
RECRUITING
Ann Arbor
START Center for Cancer Research - Midwest
RECRUITING
Grand Rapids
North Carolina
Duke Cancer Institute
RECRUITING
Durham
New York
START Center for Cancer Research - Long Island New York
RECRUITING
Lake Success
Mount Sinai
NOT_YET_RECRUITING
New York
Tennessee
Sarah Cannon Research Institute (SCRI) Oncology Partners
RECRUITING
Nashville
Vanderbilt-Ingram Cancer Center
RECRUITING
Nashville
Texas
START Center for Cancer Research - Texas
RECRUITING
Fort Worth
MD Anderson Cancer Center
RECRUITING
Houston
NEXT Oncology - Dallas
RECRUITING
Irving
South Texas Accelerated Research Therapeutics (START)
RECRUITING
San Antonio
University of Texas (UT) Health
NOT_YET_RECRUITING
San Antonio
Virginia
NEXT Oncology - Virginia
RECRUITING
Fairfax
Contact Information
Primary
Andrew Ferguson/VP Clinical Development, PhD
medical@pheast.com
434-249-2349
Time Frame
Start Date:2025-03-31
Estimated Completion Date:2031-04
Participants
Target number of participants:272
Treatments
Experimental: Dose Escalation (Phase 1a)
Nine dose levels will be sequentially tested in PHST001 monotherapy dose escalation: 0.1 mg/kg, 0.3 mg/kg, 1.0 mg/kg, 2.0 mg/kg, 4.0 mg/kg, 6.0 mg/kg, 9.0 mg/kg, 18.0 mg/kg, and 36.0 mg/kg.
Experimental: Dose Expansion (Phase 1b)
PHST001 will be administered in combination with chemotherapy for three indicated tumor types: ovarian cancer, endometrial cancer, and cholangiocarcinoma.~The first portion of Phase 1b will consist of safety run-in groups based on the chemotherapy combination. There will be six groups: 1) combination with paclitaxel, 2) combination with topotecan, 3) combination with doxorubicin, 4) combination with 5-fluorouracil, folinic acid, and irinotecan \[FOLFIRI\], 5) combination with 5-fluorouracil, folinic acid, and oxaliplatin \[FOLFOX\], and 6) combination with gemcitabine.~The second portion of Phase 1b will begin following clearance of a safety run-in group, and subsequent participants will enroll into tumor-specific expansion cohorts at a fixed dose of PHST001 in combination with chemotherapy.