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Escalation Phase for Colorectal Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
NEXT Virginia, Fairfax, VAColorectal Cancer+15 MoreBMF-219 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing a drug to treat KRAS-mutated cancer, including lung, pancreatic and colon cancer.

Eligible Conditions
  • KRAS Mutation-Related Tumors
  • Colorectal Cancer
  • Pancreatic Cancer
  • Recurrent Cancer
  • Refractory Cancer
  • Stage IV Colorectal Cancer
  • Non-Small Cell Lung Cancer (Stage IV)
  • Stage III Non-Small Cell Lung Cancer
  • Non-Small Cell Lung Cancer
  • Stage III Pancreatic Cancer
  • Stage IV Pancreatic Cancer
  • Stage IV Non-small Cell Lung Cancer
  • Stage III Colorectal Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Palbociclib
1
Elimusertib
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Study Objectives

2 Primary · 3 Secondary · Reporting Duration: 46 months

30 months
To determine the OBDs/RP2Ds of BMF-219 monotherapy in subjects with KRAS-driven unresectable, locally advanced, or metastatic NSCLC, PDAC and CRC.
To determine the OBDs/RP2Ds of BMF-219 monotherapy in subjects with unresectable, locally advanced, or metastatic NSCLC, PDAC and CRC.
46 months
To evaluate the efficacy of BMF-219 monotherapy in subjects with unresectable, locally advanced, or metastatic NSCLC, PDAC and CRC.
To evaluate the pharmacokinetics of BMF-219.
To evaluate the safety and tolerability of BMF-219 monotherapy.

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Palbociclib
1
Elimusertib
1
Cisplatin

Trial Design

2 Treatment Groups

Escalation Phase
1 of 2
Expansion Phase
1 of 2

Experimental Treatment

90 Total Participants · 2 Treatment Groups

Primary Treatment: Escalation Phase · No Placebo Group · Phase 1

Escalation Phase
Drug
Experimental Group · 1 Intervention: BMF-219 · Intervention Types: Drug
Expansion Phase
Drug
Experimental Group · 1 Intervention: BMF-219 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 46 months

Who is running the clinical trial?

Biomea Fusion Inc.Lead Sponsor
2 Previous Clinical Trials
365 Total Patients Enrolled
Stephan Morris, MDStudy DirectorBiomea Fusion Inc.

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

In what geographic locations can prospective participants access this trial?

"Patients are being accepted to participate at Roswell Park Cancer Institute in Buffalo, New York; NEXT Oncology in San Antonio, Texas; Fred Hutch, University of Washington in Seattle, California and a couple other sites." - Anonymous Online Contributor

Unverified Answer

Has the Escalation Phase received regulatory approval from the FDA?

"Due to the fledgling nature of Escalation Phase, our team has rated its safety at a 1. This is due to limited data supporting both efficacy and security checks." - Anonymous Online Contributor

Unverified Answer

Is this examination still accepting new participants?

"The records hosted on clinicaltrials.gov suggest that this trial, first published on December 1st 2022 and last updated November 20th 2022, is no longer in need of participants. However, there are still 3686 other medical studies currently open for enrolment." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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