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First-in-Human Study of the SHP2 Inhibitor BBP-398 in Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT04528836
Recruitment Status : Recruiting
First Posted : August 27, 2020
Last Update Posted : February 24, 2021
Sponsor:
Information provided by (Responsible Party):
Navire Pharma Inc.

Brief Summary:
A first-in-human study is to evaluate the safety, tolerability and maximum tolerated dose (MTD) and establish the recommended phase 2 dose (RP2D) of BBP-398, a SHP2 inhibitor, in patients with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Tumor, Solid Drug: BBP-398 (Formerly Known as IACS-15509) Phase 1

Detailed Description:
The first-in-human (FIH) study of BBP-398 will be an open-label, sequential-cohort, non-randomized, Phase 1/1B study utilizing BOIN dose escalation followed by an expansion phase in patients with MAPK pathway- or RTK-driven advanced solid tumors. The primary objective is to determine safety and tolerability of BBP-398, the MTD and RP2D. The secondary objectives are to assess the pharmacokinetic (PK) and pharmacodynamic (PD) profile, preliminary anti-tumor activity, objective response rate (ORR, complete response + partial response rate) and the duration of response (DoR) of BBP-398. The exploratory objective is to assess predictive biomarkers of response.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Phase 1/1B First-in-Human Study of the SHP2 Inhibitor BBP-398 (Formerly Known as IACS-15509) in Patients With Advanced Solid Tumors
Actual Study Start Date : November 12, 2020
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : December 2023

Arm Intervention/treatment
Experimental: Dose Escalation Level 1
Level 1 oral capsules. Each treatment cycle will be 28 days in duration with BBP-398 administered, once daily (QD).
Drug: BBP-398 (Formerly Known as IACS-15509)
oral capsules

Experimental: Dose Escalation Level 2
Level 2 oral capsules. Each treatment cycle will be 28 days in duration with BBP-398 administered, once daily (QD).
Drug: BBP-398 (Formerly Known as IACS-15509)
oral capsules

Experimental: Dose Escalation Level 3
Level 3 oral capsules. Each treatment cycle will be 28 days in duration with BBP-398 administered, once daily (QD).
Drug: BBP-398 (Formerly Known as IACS-15509)
oral capsules

Experimental: Dose Escalation Level 4
Level 4 oral capsules. Each treatment cycle will be 28 days in duration with BBP-398 administered, once daily (QD).
Drug: BBP-398 (Formerly Known as IACS-15509)
oral capsules

Experimental: Dose Escalation Level 5
Level 5 oral capsules. Each treatment cycle will be 28 days in duration with BBP-398 administered, once daily (QD).
Drug: BBP-398 (Formerly Known as IACS-15509)
oral capsules

Experimental: Dose Escalation Level 6
Level 6 oral capsules. Each treatment cycle will be 28 days in duration with BBP-398 administered, once daily (QD).
Drug: BBP-398 (Formerly Known as IACS-15509)
oral capsules

Experimental: Expansion Cohort A: Advanced KRAS G12C NSCLC
MTD/RP2D defined dose. Oral capsules Each treatment cycle will be 28 days in duration with BBP-398 administered, once daily (QD)
Drug: BBP-398 (Formerly Known as IACS-15509)
oral capsules

Experimental: Expansion Cohort B: Advanced KRAS G12C non-NSCLC
MTD/RP2D defined dose. Oral capsules Each treatment cycle will be 28 days in duration with BBP-398 administered, once daily (QD)
Drug: BBP-398 (Formerly Known as IACS-15509)
oral capsules

Experimental: Expansion Cohort C: Advanced solid tumor with other MAPK-
MTD/RP2D defined dose. Oral capsules Each treatment cycle will be 28 days in duration with BBP-398 administered, once daily (QD)
Drug: BBP-398 (Formerly Known as IACS-15509)
oral capsules

Experimental: Expansion Cohort D: Advanced EGFR-mutant NSCLC
MTD/RP2D defined dose. Oral capsules Each treatment cycle will be 28 days in duration with BBP-398 administered, once daily (QD)
Drug: BBP-398 (Formerly Known as IACS-15509)
oral capsules




Primary Outcome Measures :
  1. Determination of Maximum Tolerated Dose (MTD) of BBP-398. [ Time Frame: Completion of 1 Cycle ( 28 days) ]
    The MTD will be based on DLT.


Secondary Outcome Measures :
  1. Determination of anti-tumor activity of BBP-398 [ Time Frame: Completion of 1 Cycle ( 28 days) ]
    Anti-tumor activity will be defined by objective response rate (ORR2, complete response + partial response rate) and duration of response (DOR3)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion

  1. Male and non-pregnant females >18 years old.
  2. Patients must have a diagnosis of advanced (primary or recurrent) or metastatic solid tumor with MAPK-pathway alterations (excluding BRAF V600X) as assessed by clinically validated and/or FDA-approved molecular diagnostic and no available standard of care or curative therapies (MAPK-pathway alterations include, for example KRASG12C mutant, EGFR-mutant; see Appendix 1).
  3. Dose expansion only: Patients with the following genomically defined tumor types will be recruited.
  4. Patients must have measurable disease by RECIST v1.1.
  5. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
  6. Patients must have adequate organ function.
  7. Patients must be ≥3 weeks beyond treatment with any chemotherapy or other investigational therapy.
  8. Women of childbearing potential (WOCBP) MUST have a negative serum or urine HCG test.
  9. Patients must have the ability to understand and the willingness to sign a written informed consent document prior to the initiation of the study and any study procedures.
  10. Patients must be willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other specified study procedures.

Exclusion Criteria

  1. Patients with known active Hepatitis B, Hepatitis C infection, or HIV infection.
  2. Patients with active infection requiring intravenous (IV) antibiotics or other uncontrolled intercurrent illness requiring hospitalization. Minor infections are allowed.
  3. Patients with a history of CVA, myocardial infarction or unstable angina within the previous 6 months before starting therapy.
  4. Patients with clinically significant cardiac disease.
  5. Patients with a history of LVEF <50% within the previous 12 months.
  6. Patients with a history of retinal vein occlusion (RVO).
  7. Patients with tumors harboring known activating mutations in BRAF V600X, PTPN11 (SHP2) or RAS Q61.
  8. Patients with a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
  9. Patients with known central nervous system (CNS) tumors.
  10. Patients with known active CNS metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable.
  11. Patients who have undergone major surgery within 4 weeks prior to study enrollment.
  12. Patients who have previously received a SHP2 inhibitor.
  13. Patients with inability to swallow oral medications.
  14. Patients should not have gastrointestinal illness that would preclude the absorption of an oral agent.
  15. Patients on dialysis.
  16. Female patients who are pregnant, planning to become pregnant, or who are breastfeeding.
  17. Any patient, who in the opinion of the investigator, is likely to be unable to comply with the study procedures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04528836


Contacts
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Contact: Vaeling Clinical Operations Lead 14082031726 vaeling.miller@bridgebio.com

Locations
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United States, Colorado
Sarah Cannon Research Institute Recruiting
Denver, Colorado, United States, 80218
Contact: Study Coordinator    720-754-2610      
Principal Investigator: Gerald Falchook, MD         
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77096
Contact: Study Coordinator askMDAnderson    877-632-6789      
Principal Investigator: David Hong, MD         
NEXT Oncology Recruiting
San Antonio, Texas, United States, 78229
Contact: Study Coordinator    210-589-9500      
Principal Investigator: Karim Raghad, MD         
United States, Utah
Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Study Coordinator    888-424-2100    cancerinfo@hci.utah.edu   
Principal Investigator: Ignacio Garrido-Laguna, MD         
Sponsors and Collaborators
Navire Pharma Inc.
Investigators
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Study Chair: Carl Dambkowski, MD, VP Clinical Strategy, MD Navire Pharma Inc.
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Responsible Party: Navire Pharma Inc.
ClinicalTrials.gov Identifier: NCT04528836    
Other Study ID Numbers: NAV-1001
First Posted: August 27, 2020    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Navire Pharma Inc.:
Cancer
MAPK-pathway alterations