Recruiting
Phase 1

PHST001

Sponsor:

Pheast Therapeutics

Code:

NCT06840886

Conditions

Advanced Solid Tumors

Ovarian Cancer

Endometrial Cancer

Cholangiocarcinoma

CNS Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PHST001

Paclitaxel

Topotecan

Doxorubicin

FOLFIRI

Study Details

Brief 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 anticancer therapies (Phase 1b) in adult participants with advanced relapsed and/or refractory solid tumors (including but not limited to CNS tumors in Phase 1a only). Phase 1b will include the following cohorts 1) tumor-specific cohorts for participants with advanced relapsed and/or refractory ovarian cancer, endometrial cancer, and cholangiocarcinoma, 2) a randomized cohort for participants with ovarian cancer who will receive PHST001 in combination with mirvetuximab soravtansine, 3) a cohort for participants with advanced/metastatic breast cancer who will receive PHST001 in combination with trastuzumab deruxtecan and 4) a cohort of patients who consent to additional biomarker studies.

The study's primary objectives are to evaluate the safety and tolerability of PHST001 and determine the RP2D (Recommended Phase 2 dose) of PHST001 as monotherapy and in combination with anticancer therapies, as well as to assess the anti-tumor activity of PHST001 in combination with anticancer therapies in Phase 1b.

Conditions

Advanced Solid Tumors

Ovarian Cancer

Endometrial Cancer

Cholangiocarcinoma

CNS Tumor

Study ID

NCT06840886

Start date

Mar 31, 2025

Status verified date

Sep, 2026

Completion date

Apr, 2031

Anticipated

Primary completion date

Apr, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • Diagnosis of immunodeficiency
  • History of a previous additional malignancy, unless potentially curative treatment has been completed, with no evidence of malignancy for 2 years. Participants with basal cell carcinoma of the skin, Stage I melanoma, melanoma in situ, squamous cell carcinoma of the skin, early-stage prostate cancer, low grade neoplasms, or carcinoma in situ, excluding carcinoma in situ of the bladder, who have undergone potentially curative therapy are not excluded and can be enrolled regardless of disease-free period following completion of potentially curative therapy. Participants with early-stage breast cancer who have undergone curative intent treatment and with no disease recurrence for 2 years after treatment are not excluded.
  • Active known CNS metastases and/or carcinomatous meningitis from a systemic (non-CNS) primary malignancy. Participants with previously treated CNS metastases are eligible, provided they are radiologically and clinically stable (i.e., no evidence of progression for at least 2 weeks by repeat imaging performed during screening) and are not requiring systemic corticosteroids above the physiologic replacement for at least 7 days prior to the first dose of study treatment.
  • Received prior systemic anticancer therapy including investigational agents within 21 days or, if shorter, within 5 half-lives prior to the first dose of study treatment. Participants must have recovered from all AEs due to previous therapies to Grade ≤1 or baseline. Participants with Grade ≤2 neuropathy may be eligible. Participants with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible.
  • Prior autologous or allogeneic hematopoietic stem cell transplant or solid organ transplant.
  • Received previous treatment with another agent targeting CD24.

Study Design

Enrollment

426 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PHST001 Monotherapy

Participants will receive PHST001 monotherapy administered once every 3 weeks (Q3W). In Phase 1a, PHST001 will be evaluated in sequential dose-escalation cohorts at planned dose levels of 0.1, 0.3, 1.0, 2.0, 4.0, 6.0, 9.0, 18.0, and 36.0 mg/kg. Dose levels may be modified or additional dose levels evaluated based on emerging safety, pharmacokinetic, pharmacodynamic, and antitumor activity data. Participants in the Phase 1b biomarker cohort may also receive PHST001 monotherapy.

experimental: PHST001 + Paclitaxel

Participants will receive PHST001 in combination with paclitaxel. The combination will initially be evaluated in a Phase 1b safety run-in group. Following safety clearance, the combination may be evaluated in tumor-specific expansion cohorts, including participants with ovarian carcinoma, endometrial carcinoma, or cholangiocarcinoma, and/or in the biomarker cohort.

experimental: PHST001 + Topotecan

Participants will receive PHST001 in combination with topotecan. The combination will initially be evaluated in a Phase 1b safety run-in group. Following safety clearance, the combination may be evaluated in the ovarian carcinoma expansion cohort and/or biomarker cohort.

experimental: PHST001 + Doxorubicin

Participants will receive PHST001 in combination with doxorubicin. The combination will initially be evaluated in a Phase 1b safety run-in group. Following safety clearance, the combination may be evaluated in ovarian carcinoma or endometrial carcinoma expansion cohorts and/or the biomarker cohort.

experimental: PHST001 + FOLFIRI

Participants will receive PHST001 in combination with FOLFIRI (5-fluorouracil, folinic acid, and irinotecan). The combination will initially be evaluated in a Phase 1b safety run-in group. Following safety clearance, the combination may be evaluated in the cholangiocarcinoma expansion cohort and/or biomarker cohort.

experimental: PHST001 + FOLFOX

Participants will receive PHST001 in combination with FOLFOX (5-fluorouracil, folinic acid, and oxaliplatin). The combination will initially be evaluated in a Phase 1b safety run-in group. Following safety clearance, the combination may be evaluated in the cholangiocarcinoma expansion cohort and/or biomarker cohort.

experimental: PHST001 + Gemcitabine

Participants will receive PHST001 in combination with gemcitabine. The combination will initially be evaluated in a Phase 1b safety run-in group. Following safety clearance, the combination may be evaluated in ovarian carcinoma or cholangiocarcinoma expansion cohorts and/or the biomarker cohort.

experimental: PHST001 + Mirvetuximab Soravtansine

Participants will receive PHST001 in combination with mirvetuximab soravtansine. The combination will initially be evaluated in a Phase 1b safety run-in group. Following safety clearance, the combination may be evaluated in the ovarian carcinoma expansion cohort and/or in the biomarker cohort. Half of the participants in the randomized ovarian carcinoma cohort may be randomly assigned to receive PHST001 in combination with mirvetuximab soravtansine.

experimental: PHST001 + Trastuzumab Deruxtecan

Participants will receive PHST001 in combination with trastuzumab deruxtecan. The combination will initially be evaluated in a Phase 1b safety run-in group. Following safety clearance, the combination may be evaluated in participants with advanced or metastatic breast cancer and/or in the biomarker cohort.

active comparator: Mirvetuximab Soravtansine Monotherapy

Participants with ovarian carcinoma enrolled in the randomized Phase 1b expansion cohort will be randomized 1:1 to receive mirvetuximab soravtansine monotherapy or mirvetuximab soravtansine in combination with PHST001. Participants assigned to this arm will receive mirvetuximab soravtansine monotherapy.

Interventions

PHST001

PHST001 is an anti-CD24 macrophage checkpoint inhibitor, administered as IV infusions every 3-weeks (Q3W) dosing intervals.

Paclitaxel

Paclitaxel used as per standard of care.

Topotecan

Topotecan used as per standard of care.

Doxorubicin

Doxorubicin used as per standard of care.

FOLFIRI

FOLFIRI used as per standard of care.

FOLFOX

FOLFOX used as per standard of care.

Gemcitabine

Gemcitabine used as per standard of care.

Mirvetuximab Soravtansine

Mirvetuximab soravtansine used as per standard of care.

Trastuzumab Deruxtecan

Trastuzumab deruxtecan used as per standard of care.

Primary outcome measure

  • Frequency of Dose-Limiting Toxicities (DLTs) to assess the safety and tolerability of PHST001 as monotherapy (Phase 1a) or in combination with anticancer therapy (Phase 1b) [ Time Frame: From first dose of PHST001 through 21 days after the first dose of PHST001 ]
  • Frequency of Serious Adverse Events (SAEs) to assess the safety and tolerability of PHST001 as monotherapy (Phase 1a) or in combination with anticancer therapy (Phase 1b) [ Time Frame: From signed consent up to 90 days after the last dose of PHST001 ]
  • Frequency of Treatment Emergent Adverse Events (TEAEs) to assess the safety and tolerability of PHST001 as monotherapy (Phase 1a) or in combination with anticancer therapy (Phase 1b) [ Time Frame: From first dose up to 90 days after the last dose of PHST001 ]
  • Frequency of Treatment Related Adverse Events (TRAEs) to assess the safety and tolerability of PHST001 as monotherapy (Phase 1a) or in combination with anticancer therapy (Phase 1b) [ Time Frame: From first dose up to 90 days after the last dose of PHST001 ]
  • Frequency of Adverse Events of Special Interest (AESIs) to assess the safety and tolerability of PHST001 as monotherapy (Phase 1a) or in combination with anticancer therapy (Phase 1b) [ Time Frame: From first dose up to 90 days after the last dose of PHST001 ]
  • Frequency of AEs Leading to Dose Interruption or Treatment Discontinuation and AEs Leading to Death to assess the safety and tolerability of PHST001 as monotherapy (Phase 1a) or in combination with anticancer therapy (Phase 1b) [ Time Frame: From first dose up to 90 days after the last dose of PHST001 ]
  • Overall Response Rate (ORR) based on RECIST v1.1 to assess the preliminary antitumor activity of PHST001 in combination with anticancer therapy (Phase 1b non-randomized cohorts only) [ Time Frame: From screening and during treatment up to 2 years ]
  • Progression-Free Survival (PFS) based on RECIST v1.1 to assess the preliminary antitumor activity of PHST001 in combination with anticancer therapy (Phase 1b randomized cohort only) [ Time Frame: From screening and during treatment up to 2 years ]

Central Contacts and Locations

Central contacts

Raphaël Rousseau, Chief Medical Officer, PhD, MD

650-260-8443medical@pheast.com

Locations

Precision NextGen Oncology & Research Center

Recruiting

Beverly Hills, California, United States, 90212

Contacts

Jing Liu

424-777-0708JingL@nextgenonc.com, research@nextgenonc.com

Principal Investigator:

Kamlesh Kumar Sankhala, MD

USC Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Lorraine Martinez

Lorraine.Martinez@med.usc.edu

Stephanie Kim

Stephanie.Kim2@med.usc.edu

Stanford University School of Medicine

Recruiting

Palo Alto, California, United States, 94304

Contacts

Kayla McDaniel

650-498-7293mcda59@stanford.edu

Principal Investigator:

Oliver Dorigo, MD, PhD

Sarah Cannon Research Institute (SCRI) Oncology Partners - Denver Health One

Recruiting

Denver, Colorado, United States, 80218

Contacts

Sarah Cannon Research Institute at HCA HealthONE

720-754-2610CANN.DDUDenverGeneral@SarahCannon.com

Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Priscilla Stéve

203-464-5564Priscilla.steve@yale.edu

Principal Investigator:

Michael Cecchini, MD

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

DFCI CCTI Referrals

dfcicctiexternalreferral@dfci.harvard.edu

Principal Investigator:

Michael Dennis, MD

University of Michigan Rogel Cancer Center

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

University of Michigan Health Cancer AnswerLine

1-800-865-1125canceranswerline@med.umich.edu

Principal Investigator:

Ulka Vaishampayan, MD

START Center for Cancer Research - Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

Contacts

START HOPE Team

hopeteam@startresearch.com

Principal Investigator:

Sreenivasa Chandana, MD, PhD

START Center for Cancer Research - Long Island New York

Recruiting

Lake Success, New York, United States, 11042

Contacts

Sadia Morium

363-207-5166sadia.morium@startresearch.com

Principal Investigator:

Geraldine O'Sullivan Coyne, MD

Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Jordan Cuevas

212-824-7945jordan.cuevas@mssm.edu

Principal Investigator:

Thomas Marron, MD, PhD

Duke Cancer Institute

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Phase 1 and Immunotherapy Team

919-684-6342Phase1andImmunotherapyreferrals@duke.edu

Principal Investigator:

Niharika Mettu, MD, PhD

Sarah Cannon Research Institute (SCRI) Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

SCRI Oncology Partners - Nashville

1-877-MY-1-SCRI (691-7274)ASKSARAH@scresearch.net

Principal Investigator:

Deepak Bhamidipati, MD

Vanderbilt-Ingram Cancer Center

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Clinical Trials Office (CTO)

1-800-811-8480cip@vumc.org

Principal Investigator:

Elizabeth Davis, MD, PhD

START Center for Cancer Research - Texas

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

START HOPE Team

hopeteam@startresearch.com

Principal Investigator:

Henry Xiong, MD, PhD

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

MD Anderson Cancer Center

713-563-1930ICTNPCS@mdanderson.org

Principal Investigator:

Stéphane Champiat, MD, PhD

NEXT Oncology - Dallas

Recruiting

Irving, Texas, United States, 75039

Contacts

NEXT Referrals-Dallas

fax: 210-568-4577nxt_txreferrals@nextoncology.com

Principal Investigator:

Michael Song, MD, PhD, PharmD

START Center for Cancer Research - San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

START HOPE Team

210-593-5250hopeteam@startresearch.com

Principal Investigator:

Kyriakos Papadopoulos, MD

University of Texas (UT) Health

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Mays Cancer Center Research Team

mccresearch@uthscsa.edu

Principal Investigator:

Daruka Mahadevan, MD, PhD

NEXT Oncology - Virginia

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Carrie Friedman

adelgado@nextoncology.com

Allison Delgado

carrie.friedman@usoncology.com

More Information

Sponsor

Pheast Therapeutics

Last update posted

Oct 5, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Pheast Therapeutics on 2026-10-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.