Open-label, Dose Escalation Study of GB1275 Alone and in Combination with Anti-PD 1 Antibody in Patients with Advanced Solid Tumors or in Combination with Standard of Care with Patients with Metastatic Pancreatic Adenocarcinoma, Followed by a Dose Expansion of GB1275 with Standard of Care or in Combination with an Anti-PD-1 Antibody in Patients with Metastatic Solid Tumors
- Conditions
- Phase 1: Advanced solid tumors, metastatic pancreatic adenocarcinomaPhase 2: Specified metastatic solid tumorsTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-001879-37-GB
- Lead Sponsor
- GB006, Inc., a wholly-owned subsidiary of Gossamer Bio, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 242
1. Subjects at least 18 years of age at the time of signing the informed consent form (ICF) prior to initiation of any study specific activities/procedures.
2. For Regimen A and Regimen B: subjects with histologically or cytologically confirmed diagnosis of locally advanced or metastatic pancreatic adenocarcinoma, or esophageal adenocarcinoma, or esophageal squamous cell carcinoma, or gastric/gastroesophageal junction adenocarcinoma, or TNBC, or metastatic castrate resistant prostate cancer, or MSS colorectal adenocarcinoma.
Notes: for colorectal adenocarcinoma subject, a documented MSS tumor determined by CLIA-approved local laboratory is required for enrollment.
3. For Regimen C: the subject must have histologically and/or cytologically confirmed adenocarcinoma of the pancreas and has a diagnosis of stage IV adenocarcinoma of the pancreas (American Joint Committee on Cancer [AJCC] stage IV).
4. Subjects who have exhausted potential curative options and who are relapsed or refractory to, or intolerant of, or refuse one or more of the approved or standard of care established therapy known to provide clinical benefit for their condition.
Note: there is no limit to the number of prior treatment regimens.
5. Subject must have a site of disease that is amenable to biopsy, and be a candidate for tumor biopsy prior to the first dose of the study drug to be considered for the study. Exceptions may be granted after documented discussion with the sponsor. For subjects whose baseline tumor tissues do not contain tumor cells, submission of Formalin-fixed, paraffin embedded (FFPE) or slides (minimum of 15) from archival tissues that were collected within one year prior to the first dose of the study (if available) may be requested.
6. Subject has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
7. Demonstrate adequate organ function as defined below. All screening laboratories for organ functions should be performed within 14 days of initiating the study drug(s).
8. Male or female. Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
9. Women of childbearing potential must have negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 14 days prior to receiving the first administration of the study drug(s) and a negative urine pregnancy test on Cycle 1 Day 1 before first administration of the study drug if screening serum pregnancy test was done more than 3 days prior to the first administration of the study drug(s). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test is required.
10. Women of non-childbearing potential: Evidence of post-menopausal status. Refer to Appendix 4 (Section 10.4) for definitions.
11. Women of childbearing potential who are not abstinent and intend to be sexually active with a nonsterilized male partner must be willing to use an adequate method of contraception. Refer to Appendix 4 (Section 10.4) for contraception guidance.
12. Male subjects: Non-sterilized male subjects who are not abstinent and intend to be sexually active with a female partner of childbearing potential must use male condoms as described in Appendix 4 (Section 10.4).
13. The subject (or legally acceptable representative if applicable) provides written informed consent for the stu
1. Has a 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.
2. Has untreated or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis.
3. Any unresolved Grade 2 or greater reversible toxicity from previous anticancer therapy except alopecia or Grade 2 neuropathy.
4. Clinically significant cardiovascular disease.
5. Has an active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy within 14 days of Cycle 1 Day 1.
6. Pregnant or nursing.
7. Known history of testing positive for human immunodeficiency virus (HIV), and/or 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.
8. A serious nonmalignant disease (eg, psychiatric, substance abuse, uncontrolled intercurrent illness, etc.) that could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor.
9. Any other condition that, in the opinion of the Investigator, would prohibit the subject from participating in the study.
10. Gastrointestinal (GI) tract disease causing the inability to take oral medication.
11. Malabsorption syndrome.
12. Has active autoimmune disease requiring systemic therapy in the last 2 years prior to the first dose of study drug(s) (i.e., with use of disease modifying agents, systemic corticosteroids or immunosuppressive drugs).
Note: Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
13. A history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
14. Undergone major surgery within 4 weeks and have wound(s) not healing completely prior to Cycle 1, Day 1.
15. Received prior systemic anticancer therapies within 4 weeks of biologics and 2 weeks of chemotherapy or targeted small molecule therapy or herb supplements that are used for the treatment of the malignancy under the study (6 weeks for nitrosoureas or Mitomycin C) prior to study treatment.
Note: Prior systemic anticancer therapy is not allowed for subjects to be enrolled into Pancreatic Adenocarcinoma Expansion Cohort 1.
16. Has received prior radiotherapy within 2 weeks of start of study treatment. Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (= 2 weeks of
radiotherapy) to non-CNS disease.
17. Previously received treatment with a myeloid targeting agent for example a CSF1R inhibitor or a CCR2/5 inhibitor.
18. Use of medications that are known to definitely prolong the QT interval and/or are associated with a risk of Torsades de Pointes (TdP) within 14 days of Cycle 1 Day 1
19. Use of amiodarone within 90 days prior to Cycle 1 Day 1.
20. Received a live vaccine within 30 days prior to the first dose of study drug(s). Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette–Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; howev
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method