Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Skin and Connective Tissue Diseases

Digestive System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma, Non-Small-Cell Lung

Breast Neoplasms

Stomach Neoplasms

Prostatic Neoplasms

Carcinoma

Carcinoma, Squamous Cell

Lung Neoplasms

Small Cell Lung Carcinoma

Carcinoma, Hepatocellular

Adenocarcinoma

Triple Negative Breast Neoplasms

Carcinoma, Renal Cell

Esophageal Squamous Cell Carcinoma

Carcinoma, Transitional Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Neoplasms, Squamous Cell

Breast Diseases

Skin Diseases

Head and Neck Neoplasms

Esophageal Neoplasms

Esophageal Diseases

Stomach Cancer

Small Cell Lung Cancer

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Transitional Cell Carcinoma

Esophageal Cancer

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Paclitaxel

Gemcitabine

Pembrolizumab

Albumin-Bound Paclitaxel

Immunoglobulins

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

GB1275 Monotherapy dose escalation: Oral administration. Twice per day (BID).

GB1275 with pembrolizumab dose escalation and expansion:

GB1275 oral administration; twice per day (BID), and pembrolizumab IV administration once every 3 weeks (Q3W).

GB1275 with SOC dose escalation:

GB1275 oral administration; twice per day (BID), and nab-paclitaxel and gemcitabine per United States Prescribing Information (USPI)

GB1275 with SOC Basket Cohort in patients with newly diagnosed metastatic pancreatic cancer:

GB1275 oral administration; twice per day (BID) and nab-paclitaxel and gemcitabine per USPI.

GB1275 with pembrolizumab Basket Cohort in patients with MSS colorectal cancer:

GB1275 oral administration; twice per day (BID), and pembrolizumab IV administration once every 3 weeks (Q3W).

GB1275 with pembrolizumab Basket Cohort in patients with gastric/GEJ cancer, PD-L1 positive:

GB1275 oral administration; twice per day (BID), and pembrolizumab IV administration once every 3 weeks (Q3W).

GB1275

nab-paclitaxel and gemcitabine

pembrolizumab

This first-in-human (FIH ) study is an open-label, multicenter study that consists of a Phase 1 Dose Escalation/Expansion phase of GB1275 monotherapy or in combination with Anti-PD-1 Antibody or in combination with Standard of Care in Patients with Metastatic Pancreatic Adenocarcinoma followed by a Phase 2 Basket Expansion phase in Patients with Specified Metastatic Solid Tumors

Note: The Phase 2 portion of the study was not initiated.

Phase 1 - Dose Escalation of 3 different Regimens and Expansion, Phase 2 - Basket Expansion of 3 Cohorts

GB1275 Monotherapy and in Combination With an Anti-PD1 Antibody in Patients With Specified Advanced Solid Tumors or in Combination With Standard of Care in Patients With Metastatic Pancreatic Adenocarcinoma

A Phase 1/2, First-in-Human, Open-label, Dose Escalation Study of GB1275 Monotherapy and in Combination With an Anti-PD-1 Antibody in Patients With Specified Advanced Solid Tumors or in Combination With Standard of Care in Patients With Metastatic Pancreatic Adenocarcinoma, Followed by Basket Expansion of GB1275 With Standard of Care or in Combination With an Anti-PD-1 Antibody in Patients With Specified Metastatic Solid Tumors

Time of maximum observed plasma concentration

Area under the plasma concentration-time curve

ORR defined as the proportion of subjects with best overall confirmed response (BOCR) of either a complete response (CR) or partial response (PR) as assessed by the Investigator based on RECIST v1.1

DOR defined as time from date of objective response to first documented date of disease progression or death

TTR defined as time from first dose to first date of objective response

CBR defined as proportion of subjects with confirmed CR, PR, or stable disease (SD) at six months.

PFS defined as time from first dose to first documented date of disease progression or death.

TTP defined as time from first dose to first documented date of disease progression.

OS defined as time from first dose to date of death.

Merck Sharp & Dohme LLC

GB006, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Micronutrients

Hematinics

Vitamins

Dexamethasone

Pemetrexed

Oxaliplatin

Dexamethasone acetate

BB 1101

Folic Acid

Vitamin B Complex

Vitamin B 12

Hydroxocobalamin

Trace Elements

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Enzyme Inhibitors

Folic Acid Antagonists

Folinic Acid

Methylcobalamin

Folate

Vitamin B9

Vitamin B12

Cobalamin

Cyanocobalamin

Pembrolizumab + Pemetrexed every 21 days. Folic Acid 5 days prior to first dose of pemetrexed and daily including 21 days after last dose of pemetrexed.

Dexamethasone twice daily on the day before, the day of, and the day after each dose of pemetrexed.

Vitamin B-12 7 days prior to first dose of pemetrexed, every 9 weeks, continue until 3 weeks after last dose of pemetrexed.

Pembrolizumab + Pemetrexed + Oxaliplatin every 21 days. Folic Acid 5 days prior to first dose of pemetrexed and daily including 21 days after last dose of pemetrexed.

Dexamethasone twice daily on the day before, the day of, and the day after each dose of pemetrexed.

Vitamin B-12 7 days prior to first dose of pemetrexed, every 9 weeks, continue until 3 weeks after last dose of pemetrexed.

Pembrolizumab 200 mg IV on Day 1 of each 21 day cycle until maximum of 35 cycles.

Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle until maximum of 35 cycles.

Oxaliplatin-Dose level1: 85 mg/m2 IV on Day 1 of each 21 day cycle until a maximum of 35 cycles or until discontinued due to patient election, toxicity, disease progression.

Dose level 2: 120 mg/m2 IV on Day 1 of each 21 day cycle until a maximum of 35 cycles or until discontinued due to patient election, toxicity, disease progression.

The MTD dose of oxaliplatin in the study combination of Cohort 2 will be the recommended Phase II dose (RP2D) for the cohort expansion.

Dexamethasone-4 mg by mouth twice daily on: the day before, the day of, and the day after each dose of pemetrexed.

Folic Acid-400 micrograms by mouth daily starting 5 days prior to first dose of pemetrexed and continue daily to include 21 days after the last dose of pemetrexed.

1000 micrograms administered intramuscularly 7 days prior to the first dose of pemetrexed, every 9 weeks, and should continue until 3 weeks after the last dose of pemetrexed.

Vitamin B-12

Norman Wolmark, MD

This is a Phase Ib study to evaluate the safety and preliminary anti-tumor activity of pembrolizumab in combination with pemetrexed with or without oxaliplatin in patients with chemo-refractory microsatellite stable (MSS) metastatic colorectal cancer (mCRC) without any further standard treatment options.

The co-primary endpoints of the study are to 1) establish the recommended Phase II dose (RP2D) of pembrolizumab in combination with pemetrexed and oxaliplatin and 2) evaluate the antitumor efficacy.

The secondary aims of the study are to 1) evaluate the clinical benefit rate (CBR) of pembrolizumab in combination with pemetrexed and with pembrolizumab in combination with pemetrexed and oxaliplatin in patients with chemo-refractory MSS mCRC and 2) to estimate the progression free survival (PFS) and 3) overall survival (OS) in patients with MSS mCRC treated with pembrolizumab and pemetrexed or with pembrolizumab in combination with pemetrexed and oxaliplatin.

Patients enrolled to Cohort 1 will receive: pembrolizumab 200mg IV and pemetrexed 500 mg/m2 on Day 1 of each 21 day cycle.

Cohort 2 (the dose escalation portion of the study) will be a standard "3+3" design; 2 dose levels are planned. The first 3 to 6 patients in cohort 2 will be treated at dose level 1 and will receive pembrolizumab 200 mg IV, pemetrexed 500 mg/m2 IV and oxaliplatin 85 mg/ m2 on Day 1 of each 21 day cycle. If 1 of 3 patients in this cohort experiences a dose-limiting toxicity (DLT), see Section 6.4, 3 more patients will be added at the same dose level. If 0 of 3 initial patients or 1 of 6 patients in the cohort experiences a DLT, the dose for the next cohort will be escalated to dose level 2 and will receive pembrolizumab 200 mg IV, pemetrexed 500 mg/m2 IV and oxaliplatin 120 mg/ m2 on Day 1 of each 21 day cycle; otherwise, the combination will be considered too toxic. If ≥ 2 DLTs are experienced at any dose level, the combination will be considered too toxic and the next lower dose level will be considered the RP2D. A total of 12 patients will be treated at the RP2D as the expansion portion.

Patients in both cohorts will continue to receive study therapy (maximum of 35 cycles) unless therapy is discontinued due to patient election, toxicity, or disease progression.

Dose limiting toxicity (DLT) will be monitored during the first 21 days (Cycle 1) of each dose level in Cohort 2 and will be used for purposes of dose escalation and determination of RP2D. A DLT is defined as a non-hematologic adverse event (AE) of grade ≥ 3 or a hematologic toxicity of grade ≥ 4. Toxicity will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0.

The highest dose level tolerable without dose limiting toxicities (DLTs) in \< 2 of 6 patients will be considered the recommended phase 2 dose (RP2D) and be expanded to 12 patients.

The maximum total enrollment of the study is 33 patients. In Cohort 1, a total of 15 patients with chemo-refractory MSS mCRC will be treated for further safety assessment and a preliminary signal. In Cohort 2, 3 to 6 patients will be accrued per dose level. A total of 12 patients with chemo-refractory MSS mCRC will be treated on the RP2D for further safety and preliminary efficacy signal. Cohort 1 and Cohort 2 will be analyzed separately.

Efficacy will be evaluated as the individual best overall response as defined by a modified RECIST 1.1 (mRECIST 1.1). The objective response rate (complete response \[CR\] and partial response \[PR\]) will be determined. In either dose level cohort \> 3 patients (\> 3 of 18) with objective response (PR or CR) will warrant further investigation.

Study of Pembrolizumab With Pemetrexed and Oxaliplatin in Chemo-Refractory Metastatic Colorectal Cancer Patients

A Phase IB Study of Pembrolizumab in Combination With Pemetrexed and Oxaliplatin in Patients With Chemo-Refractory Metastatic Colorectal Cancer

Objective Response Rate using modified RECIST 1.1.

Frequency of adverse events in Cohort 1 categorized using the NCI Common Terminology Criteria for Adverse Events version 4.0.

Frequency of adverse events in Cohort 2 categorized using the NCI Common Terminology Criteria for Adverse Events version 4.0.

Rate of disease status by continuous tumor measurement using modified RECIST 1.1.

Progression-free survival (PFS). Percentage of patients alive with absence of progression assessed using RECIST 1.1 criteria.

Overall Survival. Percentage of patients alive after 1 year.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
GB1275 Monotherapy and in Combination With an Anti-PD1 Antibody in Patients With Specified Advanced Solid Tumors or in Combination With Standard of Care in Patients With Metastatic Pancreatic Adenocarcinoma	NCT04060342	Pancreatic Aden... Esophageal Aden... Esophageal Squa... Gastric Adenoca... Gastroesophagea... Triple Negative... Castration-resi... Microsatellite ... Non-small Cell ... Small-cell Lung... Head and Neck S... Urothelial Carc... Renal Cell Carc... Hepatocellular ...	GB1275 nab-paclitaxel ... pembrolizumab	18 Years -	Gossamer Bio Inc.
GB1275 Monotherapy and in Combination With an Anti-PD1 Antibody in Patients With Specified Advanced Solid Tumors or in Combination With Standard of Care in Patients With Metastatic Pancreatic Adenocarcinoma	NCT04060342	Pancreatic Aden... Esophageal Aden... Esophageal Squa... Gastric Adenoca... Gastroesophagea... Triple Negative... Castration-resi... Microsatellite ... Non-small Cell ... Small-cell Lung... Head and Neck S... Urothelial Carc... Renal Cell Carc... Hepatocellular ...	GB1275 nab-paclitaxel ... pembrolizumab	18 Years -	Gossamer Bio Inc.
Study of Pembrolizumab With Pemetrexed and Oxaliplatin in Chemo-Refractory Metastatic Colorectal Cancer Patients	NCT03626922	Metastatic Colo...	Pembrolizumab Pemetrexed Oxaliplatin Dexamethasone Folic Acid Vitamin B-12	18 Years -	NSABP Foundation Inc

Spots Global Cancer Trial Database for mss mcrc

Every month we try and update this database with for mss mcrc 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 mss mcrc

Every month we try and update this database with for mss mcrc 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 mss mcrc 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.