A Phase 1a/1b Study of the PI3Ka: RAS Breaker BBO-10203 in Subjects with Advanced Solid Tumors (The BREAKER-101 Trial)
M
Mateusz Opyrchal, MD, PhD
Primary Investigator
Enrolling By Invitation
18 years - 100 years
All
Phase
1/2
1 participants needed
1 Location
Brief description of study
What is the purpose of this study?
Phase 1a Dose Escalation/Cohort Expansion BBO-10203 Monotherapy Primary:
To evaluate the safety and tolerability of BBO-10203, an inhibitor of the PI3Kα:RAS interaction, in subjects with locally advanced unresectable or metastatic (ie, advanced) HER2-positive BC; HR-positive, HER2-negative BC; KRAS mutant NSCLC; and KRAS mutant CRC.
To evaluate the safety and tolerability of BBO-10203, an inhibitor of the PI3Kα:RAS interaction, in subjects with locally advanced unresectable or metastatic (ie, advanced) HER2-positive BC; HR-positive, HER2-negative BC; KRAS mutant NSCLC; and KRAS mutant CRC.
Secondary:
To evaluate preliminary antitumor activity of BBO-10203. To characterize the PK of BBO-10203.
To evaluate preliminary antitumor activity of BBO-10203. To characterize the PK of BBO-10203.
Phase 1a Dose Escalation BBO-10203 + Trastuzumab in Subjects with HER2-positive aBC Primary:
To determine the recommended dose of BBO-10203 to be administered in combination with trastuzumab in Phase 1b Dose Expansion by evaluation of totality of safety, PK, and efficacy data.
To determine the recommended dose of BBO-10203 to be administered in combination with trastuzumab in Phase 1b Dose Expansion by evaluation of totality of safety, PK, and efficacy data.
Secondary To evaluate preliminary antitumor activity of BBO-10203 in combination with trastuzumab.
Phase 1b Dose Expansion BBO-10203 + Trastuzumab in Subjects with HER2-positive aBC Primary:
To determine the safety and tolerability of BBO-10203 in combination with trastuzumab in subjects with HER2-positive aBC. To evaluate antitumor activity of BBO-10203 in combination with trastuzumab as measured by ORR.
To determine the safety and tolerability of BBO-10203 in combination with trastuzumab in subjects with HER2-positive aBC. To evaluate antitumor activity of BBO-10203 in combination with trastuzumab as measured by ORR.
Secondary To evaluate additional measures of antitumor activity of BBO-10203 in combination with trastuzumab. To characterize the PK of BBO-10203.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632</div>
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Advanced Solid Tumors
-
Age: 18 years - 100 years
-
Gender: All
Inclusion Criteria:
- Locally advanced and unresectable or metastatic HER2-positive advanced breast cancer (aBC), HR-positive, / HER2-negative advanced breast cancer, KRAS mutant advanced colorectal cancer (aCRC), or KRAS mutant advanced non-small cell lung cancer (aNSCLC)
- Measurable disease by RECIST v1.1</li>
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1</li>
- Adequate LVEF assessed by ECHO or MUGA
- Patients with HER2-positive aBC: Must have had at least 2 prior lines of anti-HER2-directed therapy. Only 1 prior line is acceptable where there is no other regionally available standard of care (SoC).
- Patients with HR-positive, HER2-negative aBC, KRAS mutant aCRC or aNSCLC: Must have progression on, or disease recurrence after, all available SoC treatments or in the opinion of the investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate SoC therapy.
Exclusion Criteria:
- Patients with HER2+ aBC who have had more than 1 prior line of therapy with an antibody-drug conjugate
- Patients with KRAS mutant aCRC who have BRAFV600E mutation, HER2amp, or dMMR/MSI-H tumors
- Patients with KRAS mutant aNSCLC who have tumors with other targetable driver mutations (eg, EGFR, anaplastic lymphoma kinase, ROS1/BRAF/RET/MET/EGFR exon20 insertion/NTRK/HER2)
- Patients with untreated brain metastases (exceptions apply for HER2+ aBC per protocol)
Updated on
07 Jan 2025.
Study ID: TBBO10203-101, 24962
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