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Advanced Solid TumorsPhase 1NCT06840886

A Study of PHST001 in Advanced Solid Tumors

A Phase 1 study testing PHST001, Paclitaxel and Topotecan in people with Advanced Solid Tumors and Ovarian Cancer, run by Pheast Therapeutics at 20 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PHST001, Paclitaxel and Topotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
426 participants
Where
20 sitesUnited States
Study dates
31 Mar 2025to Apr 2031
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

20 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Raphaël Rousseau, Chief Medical Officer, PhD, MD contact

650-260-8443

medical@pheast.com

20 sites in 1 country

United States20 sites, 20 recruiting

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

    University of Michigan Health Cancer AnswerLine, 1-800-865-1125, canceranswerline@med.umich.edu

    Ulka Vaishampayan, MD

    Recruiting

  • Precision NextGen Oncology & Research Center

    Beverly Hills, California, 90212

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

    Kamlesh Kumar Sankhala, MD

    Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

    DFCI CCTI Referrals, dfcicctiexternalreferral@dfci.harvard.edu

    Michael Dennis, MD

    Recruiting

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

    Recruiting

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

    Denver, Colorado, 80218

    Sarah Cannon Research Institute at HCA HealthONE, 720-754-2610, CANN.DDUDenverGeneral@SarahCannon.com

    Recruiting

  • Duke Cancer Institute

    Durham, North Carolina, 27710

    Phase 1 and Immunotherapy Team, 919-684-6342, Phase1andImmunotherapyreferrals@duke.edu

    Niharika Mettu, MD, PhD

    Recruiting

  • NEXT Oncology - Virginia

    Fairfax, Virginia, 22031

    Carrie Friedman, adelgado@nextoncology.com

    Allison Delgado, carrie.friedman@usoncology.com

    Recruiting

  • START Center for Cancer Research - Texas

    Fort Worth, Texas, 76104

    START HOPE Team, hopeteam@startresearch.com

    Henry Xiong, MD, PhD

    Recruiting

  • START Center for Cancer Research - Midwest

    Grand Rapids, Michigan, 49546

    START HOPE Team, hopeteam@startresearch.com

    Sreenivasa Chandana, MD, PhD

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    MD Anderson Cancer Center, 713-563-1930, ICTNPCS@mdanderson.org

    Stéphane Champiat, MD, PhD

    Recruiting

  • NEXT Oncology - Dallas

    Irving, Texas, 75039

    NEXT Referrals-Dallas, fax: 210-568-4577, nxt_txreferrals@nextoncology.com

    Michael Song, MD, PhD, PharmD

    Recruiting

  • START Center for Cancer Research - Long Island New York

    Lake Success, New York, 11042

    Sadia Morium, 363-207-5166, sadia.morium@startresearch.com

    Geraldine O'Sullivan Coyne, MD

    Recruiting

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

    Lorraine Martinez, Lorraine.Martinez@med.usc.edu

    Stephanie Kim, Stephanie.Kim2@med.usc.edu

    Recruiting

  • Sarah Cannon Research Institute (SCRI) Oncology Partners

    Nashville, Tennessee, 37203

    SCRI Oncology Partners - Nashville, 1-877-MY-1-SCRI (691-7274), ASKSARAH@scresearch.net

    Deepak Bhamidipati, MD

    Recruiting

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37203

    Clinical Trials Office (CTO), 1-800-811-8480, cip@vumc.org

    Elizabeth Davis, MD, PhD

    Recruiting

  • Yale Cancer Center

    New Haven, Connecticut, 06520

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

    Michael Cecchini, MD

    Recruiting

  • Mount Sinai

    New York, New York, 10029

    Jordan Cuevas, 212-824-7945, jordan.cuevas@mssm.edu

    Thomas Marron, MD, PhD

    Recruiting

  • Stanford University School of Medicine

    Palo Alto, California, 94304

    Kayla McDaniel, 650-498-7293, mcda59@stanford.edu

    Oliver Dorigo, MD, PhD

    Recruiting

  • START Center for Cancer Research - San Antonio

    San Antonio, Texas, 78229

    START HOPE Team, 210-593-5250, hopeteam@startresearch.com

    Kyriakos Papadopoulos, MD

    Recruiting

  • University of Texas (UT) Health

    San Antonio, Texas, 78229

    Mays Cancer Center Research Team, mccresearch@uthscsa.edu

    Daruka Mahadevan, MD, PhD

    Recruiting

Other trials in United States

About this study

Official title: 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

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.

Being tested
PHST001, Paclitaxel, Topotecan, Doxorubicin, FOLFIRI
Medical subject headings
Ovarian Neoplasms, Endometrial Neoplasms, Cholangiocarcinoma, Central Nervous System Neoplasms, Breast Neoplasms, Fallopian Tube Neoplasms, Carcinosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PHST001Biological

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

  • PaclitaxelDrug

    Also called Taxol

    Paclitaxel used as per standard of care.

  • TopotecanDrug

    Also called Hycamtin

    Topotecan used as per standard of care.

  • DoxorubicinDrug

    Also called Adriamycin

    Doxorubicin used as per standard of care.

  • FOLFIRIDrug

    Also called folinic acid (leucovorin), fluorouracil (5-FU), and irinotecan combination

    FOLFIRI used as per standard of care.

  • FOLFOXDrug

    Also called folinic acid (leucovorin), fluorouracil (5-FU), and oxaliplatin combination

    FOLFOX used as per standard of care.

  • GemcitabineDrug

    Also called Gemzar

    Gemcitabine used as per standard of care.

  • Mirvetuximab SoravtansineBiological

    Also called MIRV, Elahere

    Mirvetuximab soravtansine used as per standard of care.

  • Trastuzumab DeruxtecanBiological

    Also called T-DXd, Enhertu

    Trastuzumab deruxtecan used as per standard of care.

Study groups in NCT06840886
Study groupRoleWhat they receive
PHST001 MonotherapyExperimentalParticipants 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.
Receives: Biological: PHST001
PHST001 + PaclitaxelExperimentalParticipants 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.
Receives: Biological: PHST001; Drug: Paclitaxel
PHST001 + TopotecanExperimentalParticipants 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.
Receives: Biological: PHST001; Drug: Topotecan
PHST001 + DoxorubicinExperimentalParticipants 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.
Receives: Biological: PHST001; Drug: Doxorubicin
PHST001 + FOLFIRIExperimentalParticipants 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.
Receives: Biological: PHST001; Drug: FOLFIRI
PHST001 + FOLFOXExperimentalParticipants 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.
Receives: Biological: PHST001; Drug: FOLFOX
PHST001 + GemcitabineExperimentalParticipants 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.
Receives: Biological: PHST001; Drug: Gemcitabine
PHST001 + Mirvetuximab SoravtansineExperimentalParticipants 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.
Receives: Biological: PHST001; Biological: Mirvetuximab Soravtansine
PHST001 + Trastuzumab DeruxtecanExperimentalParticipants 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.
Receives: Biological: PHST001; Biological: Trastuzumab Deruxtecan
Mirvetuximab Soravtansine MonotherapyActive comparatorParticipants 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.
Receives: Biological: Mirvetuximab Soravtansine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Based on toxicities observed

    Measured: From first dose of PHST001 through 21 days after the first dose of PHST001

  2. 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)

    Based on toxicities observed

    Measured: From signed consent up to 90 days after the last dose of PHST001

  3. 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)

    Based on toxicities observed

    Measured: From first dose up to 90 days after the last dose of PHST001

  4. 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)

    Based on toxicities observed

    Measured: From first dose up to 90 days after the last dose of PHST001

  5. 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)

    Based on toxicities observed

    Measured: From first dose up to 90 days after the last dose of PHST001

  6. 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)

    Based on toxicities observed

    Measured: From first dose up to 90 days after the last dose of PHST001

  7. 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)

    Defined as the proportion of subjects with confirmed complete response (CR) or partial response (PR); a confirmed response is a response that persists on repeat-imaging ≥ 4 weeks after initial documentation of response.

    Measured: From screening and during treatment up to 2 years

  8. 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)

    Defined as the time from first dose of PHST001 to first documentation of radiographic disease progression or death, whichever occurs first.

    Measured: From screening and during treatment up to 2 years

Secondary outcomes (12)

  1. Overall Response Rate (ORR) based on RECIST v1.1 (or RANO for primary CNS Tumors) to assess the preliminary antitumor activity of PHST001 as monotherapy (Phase 1a) and in combination with anticancer therapy (Phase 1b - randomized cohort only)

    Defined as the proportion of subjects with confirmed complete response (CR) or partial response (PR); a confirmed response is a response that persists on repeat-imaging ≥ 4 weeks after initial documentation of response.

    Measured: From screening and during treatment up to 2 years

  2. Duration of Response (DOR) based on RECIST v1.1 (or RANO for primary CNS Tumors) to assess the preliminary antitumor activity of PHST001 as monotherapy (Phase 1a) and in combination with anticancer therapy (Phase 1b)

    Defined as time from date of first objective response (either CR or PR) to first documentation of radiographic disease progression.

    Measured: From screening and during treatment up to 2 years

  3. Best Overall Response (BOR) based on RECIST v1.1 (or RANO for primary CNS Tumors) to assess the preliminary antitumor activity of PHST001 as monotherapy (Phase 1a) and in combination with anticancer therapy (Phase 1b)

    Defined as the best response recorded for a participant across all time-point assessments from the start of treatment until disease progression or end of treatment.

    Measured: From screening and during treatment up to 2 years

  4. Progression-Free Survival (PFS) based on RECIST v1.1 (or RANO for primary CNS Tumors) to assess the preliminary antitumor activity of PHST001 as monotherapy (Phase 1a) and in combination with anticancer therapy (Phase 1b - non-randomized cohorts only) .

    Defined as the time from first dose of PHST001 to first documentation of radiographic disease progression or death, whichever occurs first.

    Measured: From screening and during treatment up to 2 years

  5. Overall Survival (OS) based on RECIST v1.1 (or RANO for primary CNS Tumors) to assess the preliminary antitumor activity of PHST001 as monotherapy (Phase 1a) and in combination with anticancer therapy (Phase 1b).

    Defined as the time from first dose of PHST001 to the date of death.

    Measured: From screening and during treatment up to 2 years

  6. Maximum Observed Concentration (Cmax) to characterize the serum PK of PHST001 as monotherapy (Phase 1a) or in combination with anticancer therapy (Phase 1b).

    Defined as the maximum blood concentration of a dose of PHST001

    Measured: From treatment until 90 days after last dose of PHST001

  7. Time to Maximum Concentration (tmax) to characterize the serum PK of PHST001 as monotherapy (Phase 1a) or in combination with anticancer therapy (Phase 1b)

    Defined as the time required for a dose of PHST001 to reach its maximum blood concentration (Cmax) after administration.

    Measured: From treatment until 90 days after last dose of PHST001

  8. Concentration at the End of a Dosing Interval (Ctrough) to characterize the serum PK of PHST001 as monotherapy (Phase 1a) or in combination with anticancer therapy (Phase 1b)

    Defined as the blood concentration of a dose of PHST001 at the end of the dosing interval (just prior to next drug administration).

    Measured: From treatment until 90 days after last dose of PHST001

  9. Area Under the Concentration-time Curve (AUC) to characterize the serum PK of PHST001 as monotherapy (Phase 1a) or in combination with anticancer therapy (Phase 1b)

    Defined as the total PHST001 exposure over time, calculated as the integral of the plasma concentration-time profile.

    Measured: From treatment until 90 days after last dose of PHST001

  10. Volume of Distribution at Steady-state (Vss) to characterize the serum PK of PHST001 as monotherapy (Phase 1a) or in combination with anticancer therapy (Phase 1b)

    Defined as how widely PHST001 spreads throughout the body once things have stabilized after a dose has been administered.

    Measured: From treatment until 90 days after last dose of PHST001

  11. Clearance (CL) to characterize the serum PK of PHST001 as monotherapy (Phase 1a) or in combination with anticancer therapy (Phase 1b)

    Defined as the rate at which the body "cleans out" a dose of PHST001 from the bloodstream.

    Measured: From treatment until 90 days after last dose of PHST001

  12. Terminal Elimination Half-life (t½) to characterize the serum PK of PHST001 as monotherapy (Phase 1a) or in combination with anticancer therapy (Phase 1b)

    Defined as the time it takes for the amount of PHST001 in the body to drop by half during the final phase of elimination.

    Measured: From treatment until 90 days after last dose of PHST001

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2025
  2. Study start31 Mar 2025
  3. Primary completionApr 2029 (estimated)
  4. Study completionApr 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Dose levels are 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, 36.0 mg/kg alone or in combination with anticancer therapies. In the randomized PHST001 + mirvetuximab soravtansine cohort, after a dose level has been established, patients will be randomized with a 50% chance of receiving mirvetuximab soravtansine alone as an active comparator or in combination with PHST001.
Masking
None (open label)
Enrolment
426 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06840886
Sponsor's protocol ID
PHST001-101
Status last verified
Sep 2026
First submitted
10 Feb 2025
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PHST001, Paclitaxel and Topotecan in people with Advanced Solid Tumors and Ovarian Cancer, run by Pheast Therapeutics at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Raphaël Rousseau, Chief Medical Officer, PhD, MD (650-260-8443, medical@pheast.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06840886.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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