PHST001 for Cancer

Recruiting at 9 trial locations

Overseen By Raphaël Rousseau, Chief Medical Officer, PhD, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pheast Therapeutics

Must not be taking: Steroids, Anticancer agents

Disqualifiers: CNS metastases, Recent transplants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

155 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called PHST001 for individuals with advanced solid tumors that have not responded to other treatments. The main goal is to determine the safety of PHST001 and identify the optimal dosage for future studies. For those with a solid tumor that has recurred or resisted treatment, and where standard therapies have failed, this trial might be suitable. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must not have received any systemic anticancer therapy within 21 days before starting the trial treatment.

Is there any evidence suggesting that PHST001 is likely to be safe for humans?

Research shows that PHST001 is under study to help the immune system recognize and attack cancer cells. This experimental treatment targets a protein called CD24 found on cancer cells. Specific information on how well patients handle PHST001 is not yet available, as it is currently in Phase 1 trials. This phase focuses on testing safety and determining the right dose for future studies.

At this early stage, researchers carefully monitor for any side effects while testing different doses. The FDA has granted PHST001 Fast Track status, indicating promising evidence of its potential benefits. However, more safety information will emerge as the study progresses. For those considering joining this trial, the main goals are to ensure the treatment's safety and to find the best dosage for future research. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

PHST001 is unique because it explores a new approach to treating cancer by targeting specific molecular pathways that current treatments might not address. Most existing cancer therapies, like chemotherapy and radiation, focus on killing rapidly dividing cells, which often leads to significant side effects. PHST001, however, is designed to precisely attack cancer cells with less collateral damage to healthy cells. Researchers are excited about this treatment because it has the potential to improve outcomes with fewer side effects, offering a more targeted and personalized therapy for cancer patients.

What evidence suggests that PHST001 might be an effective treatment for cancer?

Research has shown that PHST001 might help treat advanced solid tumors by boosting the body's immune system. This treatment aims to prevent tumors from evading immune detection. Specifically, PHST001 shrank tumors in early lab studies, particularly in certain types of breast cancer. The results also suggest it is generally safe and well-tolerated in initial tests. These early findings indicate that PHST001 could be a promising option for patients with difficult-to-treat cancers. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors that have stopped responding to standard treatments. Participants must have adequate blood counts, liver and kidney function, and no other medical conditions that could interfere with the study.

Inclusion Criteria

My total bilirubin levels are within the normal range.

My liver function tests are within the required range.

My lipase and amylase levels are not more than twice the upper limit.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Seven dose levels will be tested to evaluate the safety and tolerability of PHST001 and determine the RP2D

21 days per dose level

Dose Expansion

Participants receive the RP2D of PHST001 to further evaluate safety and antitumor activity

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days after the last dose

What Are the Treatments Tested in This Trial?

Interventions

• PHST001

Trial Overview

PHST001-101 is testing a new drug called PHST001 in two phases: first to find the safest dose (Dose Escalation Phase) and then to see how well it works at this dose in more people (Dose Expansion Phase).

How Is the Trial Designed?

Group I: Dose Escalation Experimental Treatment 1 Intervention

Seven dose levels will be tested in dose escalation.

Who Is Running the Clinical Trial?

Pheast Therapeutics

Lead Sponsor

Trials

1

Recruited

160+

Published Research Related to This Trial

Imatinib, a tyrosine kinase inhibitor, has significantly improved the prognosis for patients with chronic myeloid leukaemia (CML) and gastrointestinal stromal tumours (GIST), showing high rates of cytogenetic and molecular responses across all phases of CML.

The drug is well tolerated, with only mild adverse effects such as joint pain and gastrointestinal symptoms, primarily occurring in the first two years of treatment, making it a safe and effective oral option for these cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A benefit-risk assessment of imatinib in chronic myeloid leukaemia and gastrointestinal stromal tumours. Wolf, D., Rumpold, H.[2021]

In a study of 250 patients with advanced renal cell carcinoma receiving first-line treatment with signal transduction inhibitors, 520 adverse drug reactions (ADRs) were documented, with 29% leading to treatment modifications.

The most common ADRs included mucositis/stomatitis, fatigue, diarrhea, and nausea, indicating that while the pattern of ADRs aligns with clinical trials, their frequency and impact in routine clinical practice may differ significantly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse reactions in mRCC patients documented in routine practice by German office-based oncologists and uro-oncologists. Marschner, N., Müller, L., Münch, A., et al.[2022]

Imatinib mesylate has shown a high clinical response rate of 81.6% in patients with gastrointestinal stromal tumors (GIST), with 53.7% achieving a partial response and 27.9% having stable disease.

While most patients experienced only mild toxicities (grade 1 or 2), 21.1% had more severe side effects (grade 3 or higher), indicating that imatinib is relatively safe but can still cause significant adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The effect of imatinib for gastrointestinal tumor]. Mizunuma, N.[2015]

In a study of 373 cancer patients under 65 years old who received COVID-19 vaccines, 76.1% experienced mild vaccine-related adverse events (VRAEs), with the most common being sore arm, fatigue, and headaches, indicating that the vaccines are generally well-tolerated in this population.

Only 2.1% of patients experienced grade 3 VRAEs, and there were no severe reactions (grade 4/5 or anaphylaxis), suggesting that COVID-19 vaccines have a favorable safety profile for patients undergoing cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

COVID-19 Vaccine Safety in Cancer Patients: A Single Centre Experience. So, ACP., McGrath, H., Ting, J., et al.[2021]

Citations

1.

pheast.com

pheast.com/pheast-therapeutics-announces-first-patient-treated-in-phase-1-clinical-trial-of-phst001-for-patients-with-advanced-solid-tumors/

Pheast Therapeutics Announces First Patient Treated in ...

Furthermore, these data suggest that PHST001 may overcome tumor immune evasion through a differentiated approach to macrophage activation. We ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06840886

A Study of PHST001 in Advanced Solid Tumors

The study consists of two parts: Part A: Dose escalation in patients with advanced solid tumors. Approximately 40-80 in total will be in enrolled in part A, ...

3.

jitc.bmj.com

jitc.bmj.com/content/12/Suppl_2/A578

513 PHST001, a humanized anti-CD24 antibody, induces ...

PHST001 treatment significantly inhibited the growth of MFM223 triple negative breast cancer and BT474 Her2+ breast cancer in vivo (figures 4 ...

4.

targetedonc.com

targetedonc.com/view/fda-grants-fast-track-status-to-phst001-in-ovarian-cancer

FDA Grants Fast Track Status to PHST001 in Ovarian Cancer

This study is assessing the safety, tolerability, and preliminary efficacy of PHST001 in patients with advanced relapsed/refractory solid tumors ...

5.

curetoday.com

curetoday.com/view/first-patient-treated-in-trial-of-phst001-for-advanced-solid-tumors

First Patient Treated in Trial of PHST001 for Advanced ...

PHST001 has shown promising preclinical results, demonstrating macrophage activation, tumor size reduction, and a favorable safety profile.

6.

delta.larvol.com

delta.larvol.com/Products/?ProductId=9bae0b2c-e22d-4ff9-9648-19b2bf6e7c1c

PHST001 / Pheast Therap

PHST001 is an investigational anti-CD24 monoclonal antibody designed to enhance innate immune recognition and anti-tumor activity in solid tumors.

7.

onclive.com

onclive.com/view/fda-grants-fast-track-designation-to-phst001-for-ovarian-cancer

FDA Grants Fast Track Designation to PHST001 for ...

PHST001 targets CD24 to enhance immune recognition and antitumor activity in solid tumors, including ovarian cancer. The phase 1 trial evaluates ...