History of Changes for Study: NCT06299761

Study of the RNR Inhibitor BBI-825 in Subjects With Tumors With Resistance Gene Amplifications (STARMAP)

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Study Record Versions

Version	Submitted Date	Changes
1	March 7, 2024	None (earliest Version on record)
2	April 1, 2024	Recruitment Status, Study Status, Contacts/Locations and Oversight
3	April 26, 2024	Contacts/Locations and Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	BBI-825-101
Brief Title:	Study of the RNR Inhibitor BBI-825 in Subjects With Tumors With Resistance Gene Amplifications (STARMAP)
Official Title:	An Open-Label, Multicenter, First-in-Human, Dose-Escalation and Dose-Expansion, Phase 1/2 Study of BBI-825 and BBI-825 in Combination With Select Targeted Therapies in Subjects With Locally Advanced or Metastatic Solid Tumors With Resistance Gene Amplifications
Secondary IDs:

Study Status


Record Verification:	March 2024
Overall Status:	Not yet recruiting
Study Start:	March 2024
Primary Completion:	February 2027 [Anticipated]
Study Completion:	February 2027 [Anticipated]

First Submitted:	February 26, 2024
First Submitted that Met QC Criteria:	March 7, 2024
First Posted:	March 8, 2024 [Actual]

Last Update Submitted that Met QC Criteria:	March 7, 2024
Last Update Posted:	March 8, 2024 [Actual]

Sponsor/Collaborators


Sponsor:	Boundless Bio
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	No

Study Description


Brief Summary:	BBI-825 is a potent, selective, oral, small molecule inhibitor of ribonucleotide reductase (RNR). This is a first-in-human, open-label, non-randomized, 3-part, Phase 1/2 study to determine the safety profile and identify the maximum tolerated dose and recommended Phase 2 dose of BBI-825 administered as a single agent and in combination with select targeted therapies.
Detailed Description:	BBI-825 will be administered orally (PO) twice daily (BID) to subjects with locally advanced or metastatic non-resectable solid tumors, whose disease has progressed despite all standard therapies or for whom no further standard or clinically acceptable therapy exists.

Conditions


Conditions:	Solid Tumor
Keywords:	Amplification Oncogene Amplification ribonucleotide reductase inhibitor RNR inhibitor

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 1
Interventional Study Model:	Sequential Assignment
	BBI-825 single agent dose escalation
Number of Arms:	1
Masking:	None (Open Label)
Allocation:	N/A
Enrollment:	42 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Single Agent Dose Escalation Single agent BBI-825, administered orally, twice daily, in 28-day cycles	Drug: BBI-825 Oral RNR inhibitor Other Names: ribonucleotide reductase inhibitor

Outcome Measures


Primary Outcome Measures:
1.	Frequency and severity of treatment emergent adverse events (TEAEs) of BBI-825 [ Time Frame: Start of Cycle 1 until 30 days following last dose (each cycle is 28 days) ] TEAEs will be assessed and severity assigned by using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
2.	Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of BBI-825 [ Time Frame: Start of Cycle 1 until 30 days following last dose (each cycle is 28 days) ] The MTD and/or RP2D of BBI-825 will be determined.
Secondary Outcome Measures:
1.	Maximum observed plasma concentration (Cmax) of BBI-825 [ Time Frame: Start of Cycle 1 until Day 1 of last treatment cycle (each cycle is 28 days) ] Maximum observed plasma concentration (Cmax) of BBI-825 will be determined.
2.	Trough observed plasma concentration (Ctrough) of BBI-825 [ Time Frame: Start of Cycle 1 until Day 1 of last treatment cycle (each cycle is 28 days) ] Trough observed plasma concentration (Ctrough) of BBI-825 will be determined.
3.	Time to Cmax (Tmax) of BBI-825 [ Time Frame: Start of Cycle 1 until Day 1 of last treatment cycle (each cycle is 28 days) ] Time to Cmax (Tmax) of BBI-825 will be determined.
4.	Area under the concentration time curve (AUC) of BBI-825 [ Time Frame: Start of Cycle 1 until Day 1 of last treatment cycle (each cycle is 28 days) ] Area under the concentration time curve (AUC) of BBI-825 will be determined.
5.	Anti-tumor activity of BBI-825 as determined by RECISTv1.1 [ Time Frame: Start of Cycle 1 until Day 1 of last treatment cycle (each cycle is 28 days) ] Number of participants achieving a best response of progressive disease, stable disease, partial response, or complete response.

Eligibility


Minimum Age:	18 Years
Maximum Age:	99 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Locally advanced or metastatic non-resectable solid tumors, whose disease has progressed despite all standard therapies or for whom no further standard or clinically acceptable therapy exists, Availability of FFPE tumor tissue, archival or newly obtained, Measurable disease as defined by RECIST Version 1.1, Adequate hematologic function, Adequate hepatic and renal function, Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1, Other inclusion criteria per study protocol. Exclusion Criteria: Prior exposure to a selective RNR inhibitor (Note: Prior exposure to chemotherapies with nonselective RNR inhibitory activity e.g., gemcitabine is permitted), Receipt of any approved or considered standard of care anticancer drug(s) or biological product(s) within 4 weeks or 5 half-lives, Hematologic malignancies, Primary CNS malignancy, leptomeningeal disease, or symptomatic active CNS metastases, with exceptions per study protocol, Prior or concurrent malignancies, with exceptions per study protocol, History of HBV, HCV, or HIV infection, Clinically significant cardiac condition, Active or history of interstitial lung disease (ILD) or pneumonitis, or history of ILD or pneumonitis requiring steroids or other immunosuppressive medications, QTcF > 470 msec, Concurrent use of strong inhibitors or inducers of CYP3A, CYP2C8, CYP2C9, or CYP2C19, Other exclusion criteria per study protocol.

Contacts/Locations


Central Contact Person:	Sara Weymer Telephone: 16198211090 Email: ClinicalDevelopment@boundlessbio.com
Central Contact Backup:	Swadesh Sharma Telephone: 16198211090 Email: ClinicalDevelopment@boundlessbio.com
Study Officials:	Klaus Wagner, MD Study Director Boundless Bio
Locations:	United States, California
	Sarcoma Oncology Research Center Santa Monica, California, United States, 90403
	United States, Texas
	NEXT Oncology San Antonio, Texas, United States, 78229

IPDSharing


Plan to Share IPD:	No

References


Citations:
Links:
Available IPD/Information: