Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Stomach Neoplasms

Pancreatic Neoplasms

Carcinoma, Hepatocellular

Stomach Cancer

Pancreatic Cancer

Anti-Arrhythmia Agents

Vasodilator Agents

Analgesics

All Drugs and Chemicals

Adenosine

3+3 Dose escalation until MTD and/or R2PD of TT-4 is determined

TT-4 orally administered QD starting at 200 mg and will be increased to 800 mg (dosing may be increased to BID, if appropriate based on emerging safety, PK or PD data).

TT-4

Sushant Kumar, PhD

Desa Rae E Pastore, MS

The purpose of this study is to evaluate the safety and tolerability of orally administered TT-4 in subjects with advanced selected solid tumors. The dose escalation portion of the study will determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of TT-4.

Multicenter, open-label dose-escalation Phase I/II clinical study, designed to evaluate the safety, tolerability, PK, PD, anti-tumor activity, and efficacy of TT-4 in subjects diagnosed with Colorectal Cancer (CRC), Gastric cancer (GC), Hepatocellular Carcinoma (HCC) and locally advanced, unresectable, or metastatic Pancreatic Cancer (PANC); who have failed or are not eligible for standard of care treatment.

The study will be conducted in two phases. Dose escalation (Phase 1) will be to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D), safety and tolerability of TT-4 in subjects with advanced subjects diagnosed with Colorectal Cancer (CRC), Gastric cancer (GC), Hepatocellular Carcinoma (HCC) and locally advanced, unresectable, or metastatic Pancreatic Cancer (PANC); who have failed or are not eligible for standard of care treatment. Dose expansion (Phase 2) will be to further explore the safety and tolerability of the MTD and/or RP2D, PK, PD, antitumor activity, and efficacy of TT-4.

TT-4 as a Single Agent in Subjects With Advanced Selected Solid Tumors

Phase I/II First-in-Human Study of TT-4 as a Single Agent in Participants With Advanced Selected Solid Tumors

All toxicities will be graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0

This is defined as complete response (CR) or PR according to RECIST 1.1 and from the first dose until documented confirmed disease progression.

Safety assessments will be performed on a regular basis using physical examination, spontaneous AE reporting, scheduled and unscheduled laboratory assessments, and other diagnostic evaluations as indicated. Adverse events will be reported using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Time from first confirmed documented objective response (CR or PR) to the date of first confirmed documented objective progression of disease (PD) or death due to any cause whichever occurs first. If a subject has not had an event (PD or death), DR is censored at the date of last adequate tumor assessment.

Time from first dose to the date of the first confirmed documented objective progression of disease (PD) or death due to any cause, whichever occurs first.

Tarus Therapeutics, Inc.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antibodies

Antibodies, Monoclonal

Immunomodulating Agents

Immunoglobulins

All patients will receive SRF617 administered in combination with etrumadenant (AB928) and zimberelimab (AB122).

SRF617 is a fully human antibody designed to inhibit the enzymatic activity of CD39.

SRF617

Etrumadenant is an A2aR and A2bR antagonist.

etrumadenant

Zimberelimab is a fully human anti-PD-1 monoclonal antibody.

zimberelimab

Vienna Reichert, PhD

This trial will look at the safety and preliminary efficacy of SRF617 in combination with etrumadenant and zimberelimab in patients with metastatic castration-resistant prostate cancer (mCRPC).

This is a phase 2, open-label, safety and preliminary efficacy trial in patients with mCRPC using the combination of SRF617, etrumadenant (AB928), and zimberelimab (AB122).

Study of SRF617 With AB928 (Etrumadenant) and AB122 (Zimberelimab) in Patients With Metastatic Castration Resistant Prostate Cancer

A Phase 2 Trial of SRF617 in Combination With AB928 (Etrumadenant) and AB122 (Zimberelimab) in Patients With Metastatic Castration-Resistant Prostate Cancer

Response was defined as Prostate-Specific Antigen (PSA) decline of ≥ 50% (PSA50) and/or radiographic objective response of Complete Response (CR) or Partial Response (PR) per Prostate Cancer Working Group 3 (PCWG3) Criteria. The number of participants with response shows participants with any one or combination of these response types.

* CR: Disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to \< 10 millimeters (mm) in short axis
* PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum of diameters

An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious Adverse Events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

The number of participants achieving CR or PR by PCWG3 criteria is reported:

* CR: Disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to \< 10 millimeters (mm) in short axis
* PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum of diameters
* Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions from the smallest value on trial (including Baseline, if that is the smallest). The sum of diameters must also demonstrate an absolute increase of at least 5 mm. Or, the appearance of one or more lesions
* Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD

DOR was defined as the time from first documented response (PSA50 and/or CR/PR) to documented disease progression as determined by applicable disease criteria, or documented death due to any cause, whichever occured first.

DCR was defined as the percentage of participants with CR, PR, or SD lasting a minimum of 12 weeks by PCWG3 or PSA50 criteria.

PSA50 response is defined as a confirmed PSA decrease from Baseline of 50% or more based on 2 consecutive assessments measured 3 to 4 weeks apart.

PSA30 response is defined as a confirmed PSA decrease from Baseline of 30% or more based on 2 consecutive assessments measured 3 to 4 weeks apart.

Landmark PFS was defined as the percentage of participants who have not developed PFS events of death or documented disease progression as determined by applicable disease criteria.

Number of participants with SSEs per PCWG3 criteria, defined as symptomatic fracture, radiation or surgery to bone, or spinal cord compression, is reported.

Arcus Biosciences, Inc.

Surface Oncology

Coherus Biosciences, Inc.

The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.

SRF617 was administered in combination with etrumadenant and zimberelimab in 28-day cycles according to the following dosing schedule:

* SRF617 1400 mg IV every q2 weeks on Days 1 and 15
* Etrumadenant 150 mg orally daily
* Zimberelimab 480 mg IV q4 weeks on Day 1

SRF617 + Etrumadenant + Zimberelimab

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

The Safety Analysis Set included all participants who received any amount of study drug

This study was originally intended to be conducted in 2 stages (1 and 2); however, a strategic decision was made to terminate the study during Stage 1.

Hillary O'Kelly, Executive Director, Clinical Operations

The Response-Evaluable Analysis Set is defined as all participants at Baseline who received study drug and had at least 1 post-Baseline response assessment or who discontinued the treatment phase because of radiographic or symptomatic disease progression (including death caused by disease progression) within 6 weeks (+ 2 week window) of the first dose of study drug.

Number of Participants With Response

Number of Participants With Adverse Events (AEs)

Analysis was not performed as data were not collected for this outcome measure due to early study termination

Number of Participants With Response Per PCWG3 Criteria

Duration of Response (DOR)

Disease Control Rate (DCR)

SRF617 was administered in combination with etrumadenant and zimberelimab in 28-day cycles according to the following dosing schedule:

* SRF617 1400 mg IV every q2 weeks on Days 1 and 15
* Etrumadenant 150 mg orally daily
* Zimberelimab 480 mg IV q4 weeks on Day 1b.

Number of Participants With PSA50 Response

Number of Participants With PSA Decline of ≥ 30% (PSA30) Response

Time to PSA Progression

Radiographic Progression Free Survival (PFS)

Landmark PFS Rate

Participants received SRF617 administered in combination with etrumadenant and zimberelimab.

Maximum Observed Serum Concentration of SRF617 (Cmax)

Minimum Observed Serum Concentration of SRF617 Prior to Administration of Subsequent Dose (Cmin)

Number of Participants With Antidrug Antibodies (ADAs)

Number of Participants With Symptomatic Skeletal Events (SSEs)

SRF617 was administered in combination with etrumadenant and zimberelimab in 28-day cycles according to the following dosing schedule:

* SRF617 1400 milligrams (mg) intravenously (IV) every 2 weeks (q2) on Days 1 and 15
* Etrumadenant 150 mg orally daily
* Zimberelimab 480 mg IV every 4 weeks (q4) on Day 1

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
TT-4 as a Single Agent in Subjects With Advanced Selected Solid Tumors	NCT04976660	Colorectal Canc... Gastric Cancer Hepatocellular ... Pancreatic Canc...	TT-4	18 Years -	Tarus Therapeutics, Inc.
Study of SRF617 With AB928 (Etrumadenant) and AB122 (Zimberelimab) in Patients With Metastatic Castration Resistant Prostate Cancer	NCT05177770	Metastatic Cast... Prostate Cancer	SRF617 etrumadenant zimberelimab	18 Years -	Coherus Biosciences, Inc.
Study of SRF617 With AB928 (Etrumadenant) and AB122 (Zimberelimab) in Patients With Metastatic Castration Resistant Prostate Cancer	NCT05177770	Metastatic Cast... Prostate Cancer	SRF617 etrumadenant zimberelimab	18 Years -	Coherus Biosciences, Inc.

Spots Global Cancer Trial Database for a2b

Every month we try and update this database with for a2b cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for a2b

Every month we try and update this database with for a2b cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for a2b cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.