Pancreatic AdenocarcinomaPhase 1NCT04060342
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 study testing GB1275, nab-paclitaxel and gemcitabine and pembrolizumab in people with Pancreatic Adenocarcinoma and Esophageal Adenocarcinoma, run by GB006, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. at 8 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma, Esophageal Adenocarcinoma, Esophageal Squamous Cell Carcinoma
- What is being tested?
- GB1275, nab-paclitaxel and gemcitabine and pembrolizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 13 Aug 2019to 11 Apr 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Subject has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- Women of childbearing potential must use an acceptable method of contraception
- Phase 1
- Subjects with the the following:
- Regimen A and B:
- pancreatic adenocarcinoma,
Show all 16Show fewer
- esophageal adenocarcinoma, or esophageal squamous cell carcinoma, or
- gastric/gastroesophageal junction adenocarcinoma, or
- TNBC, or
- prostate cancer, or
- colorectal adenocarcinoma, or subjects with tumor types that have progressed after receiving initial treatment benefit rom the last single agent checkpoint inhibitor that is approved for the indication or in combination with standard of care therapy, for example, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell carcinoma, urothelial carcinoma, renal cell carcinoma, and hepatocellular carcinoma, etc.
- Regimen C: newly diagnosed stage IV pancreatic cancer
- Phase 2
- Cohort 1: pancreatic cancer.
- Cohort 2: colorectal cancer
- Cohort 3: gastric/GEJ adenocarcinoma
Who cannot join
- History of another malignancy within 2 years prior to first study drug(s) administration, unless the malignancy was treated with curative intent and the likelihood of relapse is <5% in 2 years
- Pregnant or nursing
- Known history of testing positive for human immunodeficiency virus (HIV)
- Gastrointestinal (GI) tract disease causing the inability to take oral medication.
- Positive test for Hepatitis B virus surface antigen (HBsAg) or a and/or positive Hep C antibody result with detectable hepatitis C virus (HCV) ribonucleic acid (RNA) indicating acute or chronic infection.
- Other protocol-defined inclusion/exclusion criteria will apply
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States7 sites
University of Colorado Hospital, Anschutz Cancer Pavilion (ACP)
Aurora, Colorado, 80045
Duke University Medical Center
Durham, North Carolina, 27710
The Sarah Cannon Research Institute/Tennessee Oncology
Nashville, Tennessee, 37203
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, 78229
UCSF Medical Center at Mission Bay
San Francisco, California, 94158
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, 63110
United Kingdom1 site
The Royals Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
About this study
Official title: 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
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
Read the detailed description
Note: The Phase 2 portion of the study was not initiated.
- Conditions
- Pancreatic Adenocarcinoma, Esophageal Adenocarcinoma, Esophageal Squamous Cell Carcinoma, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Triple Negative Breast Cancer
- Being tested
- GB1275, nab-paclitaxel and gemcitabine, pembrolizumab
- Keywords
- GEJ adenocarcinoma, TNBC, MSS mCRC, PD-L1 + gastric cancer, PD-L1 positive gastric cancer, NSCLC, SCLC, newly diagnosed stage IV pancreatic adenocarcinoma, HCC, RCC, HNSCC, Transitional Cell Carcinoma
- Medical subject headings
- Adenocarcinoma Of Esophagus, Esophageal Squamous Cell Carcinoma, Triple Negative Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Transitional Cell, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GB1275Drug
Also called Investigational
Oral
nab-paclitaxel and gemcitabineDrug
Also called Abraxane and Gemzar
IV infusion
pembrolizumabDrug
Also called Anti-PD-1
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: Regimen A - GB1275 monotherapy | Experimental | GB1275 Monotherapy dose escalation: Oral administration. Twice per day (BID). Receives: Drug: GB1275 |
| Phase 1: Regimen B - GB1275 with an Anti-PD-1 | Experimental | GB1275 with pembrolizumab dose escalation and expansion:
GB1275 oral administration; twice per day (BID), and pembrolizumab IV administration once every 3 weeks (Q3W). Receives: Drug: GB1275; Drug: pembrolizumab |
| Phase 1: Regimen C - GB1275 with Standard of Care (SOC) | Experimental | GB1275 with SOC dose escalation:
GB1275 oral administration; twice per day (BID), and nab-paclitaxel and gemcitabine per United States Prescribing Information (USPI) Receives: Drug: GB1275; Drug: nab-paclitaxel and gemcitabine |
| Phase 2: Cohort 1 - GB1275 with SOC | Experimental | 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. Receives: Drug: GB1275; Drug: nab-paclitaxel and gemcitabine |
| Phase 2: Cohort 2 - GB1275 with an Anti-PD-1 | Experimental | 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). Receives: Drug: GB1275; Drug: pembrolizumab |
| Phase 2: Cohort 3 - GB1275 with an Anti-PD-1 | Experimental | 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). Receives: Drug: GB1275; Drug: pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 Dose Escalation - Regimens A, B,and C: Incidence of dose limiting toxicities (DLTs)
Measured: Regimen A and B dose escalation Days 1-21, Regimen C dose escalation Days 8-36 days
Phase 1 Dose Escalation - Regimens A, B, and C and Phase 1 Expansion - Regimen B: Incidence of adverse events (AEs)
Measured: Regimen A and C from first dose through 30 days post last dose, Regimen B from first dose through 90 days post last dose
Phase 1 Dose Escalation - Regimens A and B: Cmax of GB1275
Maximum observed plasma concentration
Measured: From first dose through 30 days post last dose
Phase 1 Dose Escalation - Regimens A and B: Ctrough of GB1275
Trough observed plasma concentration
Measured: From first dose through 30 days post last dose
Phase 1 Dose Escalation - Regimens A and B: Tmax of GB1275
Time of maximum observed plasma concentration
Measured: From first dose through 30 days post last dose
Phase 1 Dose Escalation - Regimens A and B: t1/2 of GB1275
Terminal phase elimination half-life
Measured: From first dose through 30 days post last dose
Phase 1 Dose Escalation - Regimens A and B: AUC of GB1275
Area under the plasma concentration-time curve
Measured: From first dose through 30 days post last dose
Phase 1 Dose Escalation - Regimens A and B: CL/F of GB1275
Oral clearance
Measured: From first dose through 30 days post last dose
Phase 2 - Basket Cohorts 1, 2 and 3: Objective Response Rate (ORR)
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
Measured: 24 months
Secondary outcomes (17)
Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: Cmax of GB1275
Maximum observed plasma concentration
Measured: From first dose through 30 days post last dose
Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: Ctrough of GB1275
Trough observed plasma concentration
Measured: From first dose through 30 days post last dose
Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: Tmax of GB1275
Time of maximum observed plasma concentration
Measured: From first dose through 30 days post last dose
Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: t1/2 of GB1275
Terminal phase elimination half-life
Measured: From first dose through 30 days post last dose
Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: AUC of GB1275
Area under the plasma concentration-time curve
Measured: From first dose through 30 days post last dose
Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: CL/F of GB1275
Oral clearance
Measured: From first dose through 30 days post last dose
Phase 1 - Regimen C: Cmax of nab-paclitaxel and gemcitabine
Maximum observed plasma concentration
Measured: From first dose through 30 days post last dose
Phase 1 - Regimen C: Tmax of nab-paclitaxel and gemcitabine)
Time of maximum observed plasma concentration
Measured: From first dose through 30 days post last dose
Phase 1 - Regimen C: AUC of nab-paclitaxel and gemcitabine
Area under the plasma concentration-time curve
Measured: From first dose through 30 days post last dose
Phase 2 - Basket Cohorts 1, 2, and 3: Duration of Response (DOR)
DOR defined as time from date of objective response to first documented date of disease progression or death
Measured: 24 months
Phase 2 - Basket Cohorts 1, 2, and 3: Time to Response (TTR)
TTR defined as time from first dose to first date of objective response
Measured: 24 months
Phase 2 - Basket Cohorts 1, 2, and 3: Clinical Benefit Rate (CBR)
CBR defined as proportion of subjects with confirmed CR, PR, or stable disease (SD) at six months.
Measured: 6 months
Phase 2 - Basket Cohorts 1, 2, and 3: Progression Free Survival (PFS)
PFS defined as time from first dose to first documented date of disease progression or death.
Measured: 24 months
Phase 2 - Basket Cohorts 1, 2, and 3: Time to Progression (TTP)
TTP defined as time from first dose to first documented date of disease progression.
Measured: 24 months
Phase 2 - Basket Cohorts 1, 2, and 3: Overall Survival (OS)
OS defined as time from first dose to date of death.
Measured: 24 months
Phase 2 - Basket Cohorts 1, 2, and 3: Incidence of AEs
Measured: Basket Cohorts 1 from first dose through 30 days post last dose, Basket Cohorts 2 and 3 from first dose through 90 days post last dose.
Phase 2 - Basket Cohort 1, 2 and 3: PK profile of GB1275
Measured: Basket Cohorts 1, 2, and 3 from first dose through 30 days post last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start13 Aug 2019
- Primary completion11 Apr 2022
- Study completion11 Apr 2022
Why it stopped: No clear benefit of GB1275 was observed either as monotherapy or in combination with pembrolizumab.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Phase 1 - Dose Escalation of 3 different Regimens and Expansion, Phase 2 - Basket Expansion of 3 Cohorts
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- GB006, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04060342
- Sponsor's protocol ID
- GB1275-1101 (KEYNOTE-A36)
- Status last verified
- Aug 2022
- First submitted
- 9 Aug 2019
- Last updated
- 18 Aug 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04060342
- Acronym / sponsor ID
- GB1275-1101 (KEYNOTE-A36)
- Conditions
- Pancreatic Adenocarcinoma, Esophageal Adenocarcinoma, Esophageal Squamous Cell Carcinoma, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Triple Negative Breast Cancer
- Keywords
- GEJ adenocarcinoma, TNBC, MSS mCRC, PD-L1 + gastric cancer, PD-L1 positive gastric cancer, NSCLC, SCLC, newly diagnosed stage IV pancreatic adenocarcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No clear benefit of GB1275 was observed either as monotherapy or in combination with pembrolizumab.
- Enrolment
- 61 participants (actual)
- Lead sponsor
- GB006, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 13 Aug 2019 (actual)
- Primary completion
- 11 Apr 2022 (actual)
- Study completion
- 11 Apr 2022 (actual)
- First posted
- 19 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Note: The Phase 2 portion of the study was not initiated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Phase 1 - Dose Escalation of 3 different Regimens and Expansion, Phase 2 - Basket Expansion of 3 Cohorts
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Regimen A - GB1275 monotherapy | Experimental | Drug: GB1275GB1275 Monotherapy dose escalation: Oral administration. Twice per day (BID). |
| Phase 1: Regimen B - GB1275 with an Anti-PD-1 | Experimental | Drug: GB1275, Drug: pembrolizumabGB1275 with pembrolizumab dose escalation and expansion: GB1275 oral administration; twice per day (BID), and pembrolizumab IV administration once every 3 weeks (Q3W). |
| Phase 1: Regimen C - GB1275 with Standard of Care (SOC) | Experimental | Drug: GB1275, Drug: nab-paclitaxel and gemcitabineGB1275 with SOC dose escalation: GB1275 oral administration; twice per day (BID), and nab-paclitaxel and gemcitabine per United States Prescribing Information (USPI) |
| Phase 2: Cohort 1 - GB1275 with SOC | Experimental | Drug: GB1275, Drug: nab-paclitaxel and gemcitabineGB1275 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. |
| Phase 2: Cohort 2 - GB1275 with an Anti-PD-1 | Experimental | Drug: GB1275, Drug: pembrolizumabGB1275 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). |
| Phase 2: Cohort 3 - GB1275 with an Anti-PD-1 | Experimental | Drug: GB1275, Drug: pembrolizumabGB1275 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Subject has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- Women of childbearing potential must use an acceptable method of contraception
- Phase 1
- Regimen A and B:
- Regimen C: newly diagnosed stage IV pancreatic cancer
Key exclusion criteria (6 listed)
- History of another malignancy within 2 years prior to first study drug(s) administration, unless the malignancy was treated with curative intent and the likelihood of relapse is <5% in 2 years
- Pregnant or nursing
- Known history of testing positive for human immunodeficiency virus (HIV)
- Gastrointestinal (GI) tract disease causing the inability to take oral medication.
- Positive test for Hepatitis B virus surface antigen (HBsAg) or a and/or positive Hep C antibody result with detectable hepatitis C virus (HCV) ribonucleic acid (RNA) indicating acute or chronic infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GB1275Also: InvestigationalOral | Drug | Phase 1: Regimen A - GB1275 monotherapy, Phase 1: Regimen B - GB1275 with an Anti-PD-1, Phase 1: Regimen C - GB1275 with Standard of Care (SOC), Phase 2: Cohort 1 - GB1275 with SOC, Phase 2: Cohort 2 - GB1275 with an Anti-PD-1, Phase 2: Cohort 3 - GB1275 with an Anti-PD-1 |
| nab-paclitaxel and gemcitabineAlso: Abraxane and GemzarIV infusion | Drug | Phase 1: Regimen C - GB1275 with Standard of Care (SOC), Phase 2: Cohort 1 - GB1275 with SOC |
| pembrolizumabAlso: Anti-PD-1IV infusion | Drug | Phase 1: Regimen B - GB1275 with an Anti-PD-1, Phase 2: Cohort 2 - GB1275 with an Anti-PD-1, Phase 2: Cohort 3 - GB1275 with an Anti-PD-1 |
Primary outcome
Phase 1 Dose Escalation - Regimens A, B,and C: Incidence of dose limiting toxicities (DLTs)
Time frame: Regimen A and B dose escalation Days 1-21, Regimen C dose escalation Days 8-36 days
Phase 1 Dose Escalation - Regimens A, B, and C and Phase 1 Expansion - Regimen B: Incidence of adverse events (AEs)
Time frame: Regimen A and C from first dose through 30 days post last dose, Regimen B from first dose through 90 days post last dose
Phase 1 Dose Escalation - Regimens A and B: Cmax of GB1275
Time frame: From first dose through 30 days post last dose
Maximum observed plasma concentration
Phase 1 Dose Escalation - Regimens A and B: Ctrough of GB1275
Time frame: From first dose through 30 days post last dose
Trough observed plasma concentration
Phase 1 Dose Escalation - Regimens A and B: Tmax of GB1275
Time frame: From first dose through 30 days post last dose
Time of maximum observed plasma concentration
Phase 1 Dose Escalation - Regimens A and B: t1/2 of GB1275
Time frame: From first dose through 30 days post last dose
Terminal phase elimination half-life
Phase 1 Dose Escalation - Regimens A and B: AUC of GB1275
Time frame: From first dose through 30 days post last dose
Area under the plasma concentration-time curve
Phase 1 Dose Escalation - Regimens A and B: CL/F of GB1275
Time frame: From first dose through 30 days post last dose
Oral clearance
Phase 2 - Basket Cohorts 1, 2 and 3: Objective Response Rate (ORR)
Time frame: 24 months
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
17 secondary outcomes
Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: Cmax of GB1275
Time frame: From first dose through 30 days post last dose
Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: Ctrough of GB1275
Time frame: From first dose through 30 days post last dose
Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: Tmax of GB1275
Time frame: From first dose through 30 days post last dose
Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: t1/2 of GB1275
Time frame: From first dose through 30 days post last dose
Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: AUC of GB1275
Time frame: From first dose through 30 days post last dose
Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: CL/F of GB1275
Time frame: From first dose through 30 days post last dose
Phase 1 - Regimen C: Cmax of nab-paclitaxel and gemcitabine
Time frame: From first dose through 30 days post last dose
Phase 1 - Regimen C: Tmax of nab-paclitaxel and gemcitabine)
Time frame: From first dose through 30 days post last dose
Phase 1 - Regimen C: AUC of nab-paclitaxel and gemcitabine
Time frame: From first dose through 30 days post last dose
Phase 2 - Basket Cohorts 1, 2, and 3: Duration of Response (DOR)
Time frame: 24 months
Phase 2 - Basket Cohorts 1, 2, and 3: Time to Response (TTR)
Time frame: 24 months
Phase 2 - Basket Cohorts 1, 2, and 3: Clinical Benefit Rate (CBR)
Time frame: 6 months
Phase 2 - Basket Cohorts 1, 2, and 3: Progression Free Survival (PFS)
Time frame: 24 months
Phase 2 - Basket Cohorts 1, 2, and 3: Time to Progression (TTP)
Time frame: 24 months
Phase 2 - Basket Cohorts 1, 2, and 3: Overall Survival (OS)
Time frame: 24 months
Phase 2 - Basket Cohorts 1, 2, and 3: Incidence of AEs
Time frame: Basket Cohorts 1 from first dose through 30 days post last dose, Basket Cohorts 2 and 3 from first dose through 90 days post last dose.
Phase 2 - Basket Cohort 1, 2 and 3: PK profile of GB1275
Time frame: Basket Cohorts 1, 2, and 3 from first dose through 30 days post last dose.
Results and safety
The study was stopped early (reason given: No clear benefit of GB1275 was observed either as monotherapy or in combination with pembrolizumab.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GB1275, nab-paclitaxel and gemcitabine and pembrolizumab in people with Pancreatic Adenocarcinoma and Esophageal Adenocarcinoma, run by GB006, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. at 8 sites in 2 countries.
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 16 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: stopped early, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, United Kingdom. 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?
The study was stopped early (reason given: No clear benefit of GB1275 was observed either as monotherapy or in combination with pembrolizumab.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1 Dose Escalation - Regimens A, B,and C: Incidence of dose limiting toxicities (DLTs) (time frame: Regimen A and B dose escalation Days 1-21, Regimen C dose escalation Days 8-36 days). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Aug 2022.