Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Adenocarcinoma

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Anti-Arrhythmia Agents

Vasodilator Agents

Analgesics

Paclitaxel

Gemcitabine

Albumin-Bound Paclitaxel

Immunomodulating Agents

Adenosine

Tubulin Modulators

Antimitotic Agents

Antimetabolites

TTX-030 plus nab-paclitaxel and gemcitabine

TTX-030 plus budigalimab plus nab-paclitaxel and gemcitabine

TTX-030, nab-paclitaxel and gemcitabine

TTX-030, budigalimab, nab-paclitaxel and gemcitabine

Nab-Paclitaxel and gemcitabine

Trishula Therapeutics, Inc.

This is a Phase 2, multicenter, open-label, 3-arm, randomized, parallel group study to evaluate the efficacy and safety of TTX-030 with or without budigalimab in combination with chemotherapy (gemcitabine + nab-paclitaxel) in subjects with metastatic PDAC who did not have prior treatment for metastatic disease and are eligible to receive gemcitabine and nab-paclitaxel chemotherapy as SOC.

Phase 2 Study of TTX-030 and Chemotherapy With or Without Budigalimab for 1L mPDAC Patients

An Open-Label Multicenter 3-Arm Randomized Phase 2 Study to Assess the Efficacy and Safety of TTX-030 and Chemotherapy With or Without Budigalimab, Compared to Chemotherapy Alone, for the Treatment of Patients Not Previously Treated for Metastatic Pancreatic Adenocarcinoma

PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first

ORR is defined as the percentage of subjects who achieve best overall response (BOR) of either complete response (CR) or partial response (PR)

DoR will be defined as the time from the first documentation of disease response (CR or PR) until first documentation of progression or death from any cause, whichever comes first.

OS is defined as the time from randomization until death due to any cause.

Type, severity, and frequency of treatment-emergent AEs

AbbVie

Camurati-Engelmann Disease

ES014 doses will be escalated in patients with advanced solid tumors.

Part 2 of the study will consist of 4 expansion cohorts at the recommended optimal biological dose determined in Part 1 dose escalation.

ES014 is administered via intravenous infusion, once every 14 days, every 28 days as a treatment cycle for a maximum treatment duration per patient of 2 years.

ES014

Chang Su

Shun Lu, Doctor

The purpose of this first-in-human, open-label, multicenter, non-randomized study designed to determine the maximum tolerated dose (MTD)/maximum administered dose (MAD), optimal biological dose (OBD), and recommended phase 2 dose (RP2D) of ES014 by evaluating the safety, tolerability, PK, pharmacodynamics, and preliminary clinical activity of ES014 administered intravenously to subjects with advanced solid tumors.

A Study of ES014 in Patients With Locally Advanced or Metastatic Solid Tumours

An Open-label, Multicenter, Dose-escalation and Cohort Expansion Phase 1 Clinical Study of ES014 Administered in Patients Locally Advanced or Metastatic Solid Tumours

Adverse events will be assessed and assigned by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.

Evaluation of dose-limiting toxicity (DLT)

Maximum observed serum concentration (Cmax) of ES014 will be measured.

Trough observed serum concentration (Ctrough)of ES014 will be measured.

Area under the serum concentration time curve (AUC) of ES014 will be measured.

Time to Cmax (Tmax) of ES014 will be measured.

The terminal elimination half-life (t 1/2) of ES014 will be measured.

A pharmacokinetic measurement of the volume of plasma from which ES014 is completely removed per unit time.

The amount of of ES014 in the body divided by the plasma concentration will be measured.

The presence and the frequency of anti-drug antibodies (ADA) against ES014 will be measured.

Tumor response will be measured by the revised Response Evaluation Criteria in Solid Tumors version 1.1 (RECISTv1.1) by Investigator assessment.

Elpiscience (Suzhou) Biopharma, Ltd.

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Urinary Bladder Neoplasms

Pembrolizumab

Docetaxel

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

TTX-030 plus budigalimab (selected tumors evaluated in expansion)

TTX-030 plus budigalimab plus nab-paclitaxel + gemcitabine

TTX-030 plus nab-paclitaxel + gemcitabine

TTX-030, budigalimab and mFOLFOX6

TTX-030, budigalimab and docetaxel

TTX-030 and mFOLFOX6

TTX-030 and budigalimab

TTX-030 and pembrolizumab

Budigalimab and mFOLFOX6

This is a phase 1/1b study of TTX-030 in combination therapy, an antibody that inhibits CD39 enzymatic activity, leading to accumulation of pro-inflammatory adenosine triphosphate (ATP) and reduction of immunosuppressive adenosine, which may change the tumor microenvironment and promote anti-tumor immune response.

This trial will study the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of TTX-030 in combination with immunotherapy and/or standard chemotherapies.

TTX-030 in Combination With Immunotherapy and/or Chemotherapy in Subjects With Advanced Cancers

Phase 1/1b Study to Evaluate the Safety and Activity of TTX-030 (Anti-CD39) in Combination With Pembrolizumab or Budigalimab and/or Chemotherapy in Subjects With Advanced Solid Tumors

Number of study subjects experiencing adverse events (AEs), dose-limiting toxicities, and serious adverse events (SAEs). Safety profile will be assessed through laboratory evaluations, vital signs, and physical examinations.

ORR is defined as the proportion of subjects with CR or PR

DoR will be defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.

DCR is defined as the proportion of subjects with CR, PR, or SD

PFS is measured from documentation of progression or death from any cause, whichever occurs first

Serum concentrations of TTX-030 will be tabulated

Stomach Neoplasms

Stomach Cancer

The monotherapy dose escalation portion of the study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of SRF617 as monotherapy in up to 36 patients with advanced solid tumors.

The monotherapy tumor biopsy expansion portion of the study will further evaluate the safety and intratumoral pharmacodynamics of SRF617 monotherapy in up to 20 patients at cleared and recommended phase 2 dose levels.

This portion of the study will evaluate the safety, tolerability, PK, and preliminary efficacy of SRF617 in combination with gemcitabine + albumin-bound paclitaxel in patients with locally advanced or metastatic solid tumors.

This portion of the study will evaluate the safety, tolerability, PK, and preliminary efficacy of SRF617 in combination with pembrolizumab (Keytruda®) in patients with locally advanced or metastatic solid tumors.

Enrollment at the recommended phase 2 combination dose may be expanded to include approximately 10 additional patients with advanced pancreatic ductal adenocarcinoma (PDAC) to further evaluate safety with SRF617 and gemcitabine + albumin-bound paclitaxel combination therapy.

Enrollment at the recommended phase 2 combination dose may be expanded to include approximately 28 additional patients with 2 anti-PD-(L) 1 naive HER2 negative gastric cancer (GC) or gastroesophageal junction (GEJ) adenocarcinoma to further evaluate safety with SRF617 and pembrolizumab combination therapy.

Enrollment at the recommended phase 2 combination dose established in the combination dose escalation arms (if recommended phase 2 combination doses differ, the lower of the starting 2 doses will be used) may be expanded to include up to approximately 30 additional patients with advanced 1L PDAC.

Enrollment at the recommended phase 2 combination dose may be expanded to include approximately 29 additional patients with anti-PD-(L) 1 relapsed/refractory PD-L1+ HER2 negative gastric cancer (GC) or gastroesophageal junction (GEJ) adenocarcinoma or advanced PD-L1+ NSCLC to further evaluate safety with SRF617 and pembrolizumab combination therapy.

SRF617 prevents CD39 mediated conversion of adenosine triphosphate (ATP) and adenosine diphosphate (ADP) to adenosine monophosphate (AMP) and phosphate, leading to an increase in extracellular ATP and a reduction in adenosine levels within the tumor microenvironment (TME). There is an important role for extracellular ATP and adenosine in cancer maintenance and progression, and maintaining high levels of ATP (and low levels of adenosine) in the TME may have anticancer therapeutic activity.

SRF617

Gemcitabine as an intravenous (IV) infusion

Albumin-bound paclitaxel as an IV infusion

Alison O'Neill, MD

A Phase 1, first-in-human, monotherapy and combination dose escalation and expansion study of SRF617.

A Phase 1, open-label, first-in-human, study of SRF617, consisting of a monotherapy dose escalation, a monotherapy tumor biopsy expansion, combination dose escalations, and combination safety and efficacy expansions that will enroll patients with advanced solid tumors. The monotherapy dose escalation portion of the study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of SRF617 as monotherapy in patients with advanced solid tumors. The monotherapy tumor biopsy expansion portion of the study will further evaluate the safety and intratumoral pharmacodynamics of SRF617 monotherapy. The combination therapy dose escalation portion of the study will evaluate the safety, tolerability, PK, and preliminary efficacy of SRF617 in combination with gemcitabine + albumin-bound paclitaxel, or SRF617 in combination with pembrolizumab, in patients with locally advanced or metastatic solid tumors. Once the SRF617 combination recommended Phase 2 doses are established, additional patients with select solid tumors may be enrolled in the respective combination expansion arm of the study. An additional quadruplet combination will also be explored in patients with advanced first line (1L) PDAC (i.e., SRF617 + pembrolizumab + gemcitabine + albumin-bound paclitaxel).

Study of SRF617 in Patients With Advanced Solid Tumors

A Phase 1 Study of SRF617 in Patients With Advanced Solid Tumors

Evaluation of dose-limiting toxicity (DLT).

Safety and tolerability of SRF617 monotherapy and combination therapy will be assessed by summarizing adverse events (AEs) and will be based on treatment-emergent AEs (TEAEs). A TEAE is an AE that emerges or worsens in the period from the first dose of study drug to 30 days after the last dose of study drug assessed by per CTCAE version 5.0 or higher.

Serum concentrations of SRF617 will be collected and analyzed to evaluate the PK of SRF617.

Pharmacodynamics of SRF617 will be evaluated via serum target occupancy.

ORR will be estimated by the percentage of patients achieving a best overall response of CR or PR per iRECIST.

DoR is defined as the time from the first documented response (CR or PR) to documented disease progression as determined by applicable disease criteria, or documented death due to any cause, whichever occurs first.

DCR is defined as the percentage of patients with CR, partial PR, or stable disease lasting a minimum of 12 weeks.

PFS is defined as the time from the first treatment on study with study drug to documented disease progression as determined by applicable disease criteria or death.

Landmark PFS is defined as the percentage of patients who have not developed PFS events (ie, death or documented disease progression as determined by applicable disease criteria) at 6 months, 1 year, 1.5 years, and 2 years.

Levels of intratumoral CD39 enzymatic activity will be evaluated in patients receiving pretreatment and on-treatment tumor biopsies via an in situ ATPase histochemistry assay.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase 2 Study of TTX-030 and Chemotherapy With or Without Budigalimab for 1L mPDAC Patients	NCT06119217	Pancreatic Canc...	TTX-030, nab-pa... TTX-030, budiga... Nab-Paclitaxel ...	18 Years -	Trishula Therapeutics, Inc.
A Study of ES014 in Patients With Locally Advanced or Metastatic Solid Tumours	NCT05717348	Solid Tumor Locally Advance... Metastatic Soli...	ES014	18 Years -	Elpiscience (Suzhou) Biopharma, Ltd.
TTX-030 in Combination With Immunotherapy and/or Chemotherapy in Subjects With Advanced Cancers	NCT04306900	Solid Tumor, Ad...	TTX-030, budiga... TTX-030, budiga... TTX-030 and mFO... TTX-030 and bud... TTX-030, budiga... TTX-030 and pem... TTX-030, nab-pa... Budigalimab and...	18 Years - 110 Years	Trishula Therapeutics, Inc.
Study of SRF617 in Patients With Advanced Solid Tumors	NCT04336098	Advanced Solid ...	SRF617 Gemcitabine Albumin-Bound P... Pembrolizumab	18 Years -	Surface Oncology

Spots Global Cancer Trial Database for cd39

Every month we try and update this database with for cd39 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 cd39

Every month we try and update this database with for cd39 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 cd39 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.