BI 1810631 for Advanced Cancer
Recruiting in Palo Alto (17 mi)
+88 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Boehringer Ingelheim
Must not be taking: Systemic anti-cancer, Investigational drugs
Disqualifiers: Major surgery, Previous malignancies, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
This trial is testing a new medicine called BI 1810631, which is taken as tablets. It targets adults with advanced cancers that have specific genetic changes and have not responded to other treatments. The goal is to find a safe dose and see if it can help shrink tumors.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications, but it mentions that patients who need to continue restricted medications or drugs that might interfere with the trial cannot participate. It's best to discuss your specific medications with the study team.
What data supports the effectiveness of the drug BI 1810631 for advanced cancer?
Research on similar drugs, like poziotinib, shows promising results in treating cancers with HER2 mutations, which are similar to the target of BI 1810631. These drugs have shown effectiveness in non-small cell lung cancer and breast cancer by targeting the HER2 protein, which is involved in cancer growth.12345
What makes the drug BI 1810631 unique for treating advanced cancer?
Research Team
Eligibility Criteria
Adults with advanced cancers showing changes in the HER2 gene, who have not responded to previous treatments, can join this trial. They must be generally healthy, able to take tablets daily or twice a day, and willing to use effective birth control. People with certain blood counts and organ functions are eligible. Those with brain metastases that don't need immediate treatment may also qualify.Inclusion Criteria
- Life expectancy of at least 12 weeks at the start of treatment in the opinion of the investigator.
I have signed and understand the consent form for this trial.
- Additional inclusion criteria for Phase Ib - Cohort 3 only:
See 31 more
Exclusion Criteria
My ductal carcinoma in situ has been treated successfully.
I had another cancer that was treated and is now considered cured.
I need to keep taking certain medications that may affect the trial.
See 9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Dose Escalation
Participants receive escalating doses of zongertinib to determine the maximum tolerated dose
3 weeks (per cycle)
Regular health checks and monitoring
Dose Expansion
Participants receive the determined dose of zongertinib to assess tumor response
Up to 12 months
Regular health checks and monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- BI 1810631 (Small Molecule Inhibitor)
Trial OverviewThe trial is testing BI 1810631's tolerable doses on various advanced cancers (Part 1) and its effectiveness in shrinking tumors in non-small cell lung cancer patients with specific HER2 mutations (Part 2). Participants will receive BI 1810631 orally as part of their ongoing treatment regimen while being monitored for health and tumor response.
Participant Groups
9Treatment groups
Experimental Treatment
Group I: Phase Ib - Dose expansion part: Cohort 8Experimental Treatment1 Intervention
Cohort only in the United States of America (USA)
Group II: Phase Ib - Dose expansion part: Cohort 7Experimental Treatment1 Intervention
Cohort only in Japan
Group III: Phase Ib - Dose expansion part: Cohort 6Experimental Treatment1 Intervention
Cohort only in the United States of America (USA)
Group IV: Phase Ib - Dose expansion part: Cohort 5Experimental Treatment1 Intervention
Group V: Phase Ib - Dose expansion part: Cohort 4Experimental Treatment1 Intervention
Group VI: Phase Ib - Dose expansion part: Cohort 3Experimental Treatment1 Intervention
Group VII: Phase Ib - Dose expansion part: Cohort 2Experimental Treatment1 Intervention
Group VIII: Phase Ib - Dose expansion part: Cohort 1Experimental Treatment1 Intervention
Group IX: Phase Ia - Dose escalation partExperimental Treatment1 Intervention
Consecutive cohorts of patients treated with escalating doses of BI 1810631 monotherapy.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Tennessee Oncology, PLLCNashville, TN
Winship Cancer InstituteAtlanta, GA
Hawaii Cancer Care - HonoluluHonolulu, HI
Duke University Medical CenterDurham, NC
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
Boehringer Ingelheim
Lead Sponsor
Trials
2566
Patients Recruited
16,150,000+
Findings from Research
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Poziotinib in non-small-cell lung cancer patients with HER2 exon 20 mutations: A pooled analysis of randomized clinical trials.Wang, BC., Kuang, BH., Liu, XX., et al.[2022]
Phase II trials of trastuzumab deruxtecan and poziotinib, both targeting HER2, show promising efficacy in treating HER2-mutant non-small cell lung cancer.
These results suggest that these agents could establish new standards of care for patients with this specific type of lung cancer.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Targeting HER2 May Overtake Chemo, Immunotherapy in NSCLC.[2022]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Genomic landscape and efficacy of HER2-targeted therapy in patients with HER2-mutant non-small cell lung cancer.Han, Y., Xiong, Y., Lu, T., et al.[2023]
HER2 is a critical target in breast cancer treatment, as it is linked to tumor growth and poor prognosis in patients with high-risk HER2-positive breast cancer.
Prospective trials are being conducted to evaluate the effectiveness of anti-HER2 monoclonal antibody therapy, which may improve outcomes for patients with node-positive HER2-positive breast cancer, especially when combined with chemotherapy.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
The role of adjuvant monoclonal antibody therapy for breast cancer: rationale and new studies.Perez, EA.[2019]
HER2-targeted therapies have significantly improved the prognosis for patients with HER2-positive advanced breast cancer, but resistance to these treatments is common, making ongoing research essential.
New strategies, including novel anti-HER2 antibodies, antibody-drug conjugates, and combination therapies targeting the tumor microenvironment and specific signaling pathways, are being developed to overcome resistance and improve treatment outcomes.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
New Therapeutics in HER2-Positive Advanced Breast Cancer: Towards a Change in Clinical Practices?pi.Mezni, E., Vicier, C., Guerin, M., et al.[2020]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
A Phase I, Open-Label, Dose Confirmation, Escalation, and Expansion Trial of BI 1810631 as Monotherapy in Patients With Advanced or Metastatic Solid Tumors With HER2 Aberrations.Heymach, J., Opdam, F., Barve, M., et al.[2023]
The maximum tolerated dose (MTD) of poziotinib when combined with paclitaxel and trastuzumab for treating HER2-positive advanced gastric cancer was determined to be 8 mg/day, with manageable toxicity observed in the study.
In a cohort of 44 patients, the treatment combination showed promising efficacy, with a 21.9% objective response rate and median progression-free survival of 13 weeks, indicating potential benefits for patients previously treated with chemotherapy.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
A phase I/II study of poziotinib combined with paclitaxel and trastuzumab in patients with HER2-positive advanced gastric cancer.Kim, TY., Han, HS., Lee, KW., et al.[2023]
In a study of 194 patients with metastatic breast cancer, the pan-ErbB receptor inhibitor CI-1033 showed limited overall effectiveness, with only 1.5% response rates in lower dose arms and a slightly better 7.3% in the highest dose arm, indicating minimal clinical activity in heavily pretreated patients.
The highest dose (450 mg) led to a significant increase in severe side effects, with 80.4% of patients experiencing grade 3/4 adverse events, prompting early discontinuation of this regimen, while the 50 mg dose was better tolerated.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
A randomized, phase II, dose-finding study of the pan-ErbB receptor tyrosine-kinase inhibitor CI-1033 in patients with pretreated metastatic breast cancer.Rixe, O., Franco, SX., Yardley, DA., et al.[2022]
In the ZENITH20-C4 trial involving 80 treatment-naive patients with NSCLC and HER2 exon 20 insertions, poziotinib demonstrated a 39% objective response rate and a 73% disease control rate, indicating significant efficacy in this patient population.
The treatment was associated with manageable side effects, with the most common grade 3 adverse events being rash, stomatitis, and diarrhea, suggesting that poziotinib is a viable option for patients with these specific mutations.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Poziotinib in Treatment-Naive NSCLC Harboring HER2 Exon 20 Mutations: ZENITH20-4, A Multicenter, Multicohort, Open-Label, Phase 2 Trial (Cohort 4).Cornelissen, R., Prelaj, A., Sun, S., et al.[2023]
References
Poziotinib in non-small-cell lung cancer patients with HER2 exon 20 mutations: A pooled analysis of randomized clinical trials. [2022]
Targeting HER2 May Overtake Chemo, Immunotherapy in NSCLC. [2022]
Genomic landscape and efficacy of HER2-targeted therapy in patients with HER2-mutant non-small cell lung cancer. [2023]
The role of adjuvant monoclonal antibody therapy for breast cancer: rationale and new studies. [2019]
New Therapeutics in HER2-Positive Advanced Breast Cancer: Towards a Change in Clinical Practices?pi. [2020]
A Phase I, Open-Label, Dose Confirmation, Escalation, and Expansion Trial of BI 1810631 as Monotherapy in Patients With Advanced or Metastatic Solid Tumors With HER2 Aberrations. [2023]
A phase I/II study of poziotinib combined with paclitaxel and trastuzumab in patients with HER2-positive advanced gastric cancer. [2023]
A randomized, phase II, dose-finding study of the pan-ErbB receptor tyrosine-kinase inhibitor CI-1033 in patients with pretreated metastatic breast cancer. [2022]
Poziotinib in Treatment-Naive NSCLC Harboring HER2 Exon 20 Mutations: ZENITH20-4, A Multicenter, Multicohort, Open-Label, Phase 2 Trial (Cohort 4). [2023]