Part B: Ovarian Dose Expansion for Breast Cancer

Dana-Farber Cancer Institute, Boston, MA
Breast Cancer+8 More ConditionsINX-315 - Drug
Eligibility
18+
All Sexes

Study Summary

This trial is testing a drug that could treat human cancers by blocking a certain protein. It will evaluate safety, effectiveness, and other factors.

Eligible Conditions
  • Solid Tumors
  • Triple Negative Breast Cancer
  • Hormone Receptor Positive Tumor
  • Advanced Cancer
  • Metastatic Breast Cancer
  • Breast Cancer
  • CCNE1 Amplification
  • Metastatic Cancer
  • Ovarian Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1 & 2

Study Objectives

5 Primary · 11 Secondary · Reporting Duration: Up to 36 months

28 days
Part A: Evaluate the occurrence of dose-limiting toxicities (DLTs) during Cycle 1
Day 15
Part A and B: Characterize the Area under the plasma concentration versus time curve from time 0 to the end of the dosing interval (AUC0-24h)
Part A and B: Characterize the maximum plasma concentration (Cmax)
Part A and B: Characterize the oral clearance (CL/F)
Part A and B: Characterize the terminal half-life (t1/2)
Part A and B: Characterize the time to maximum plasma concentration (Tmax)
Up to 12 months
Part A and B: Evaluate the incidents of treatment emergent adverse events and laboratory abnormalities
Part A: Recommend at least two doses of INX-315 to be evaluated in the expansion phase
Up to 36 months
Part A and B: Disease control rate (DCR)
Part A and B: Duration of response (DOR)
Part A and B: Overall survival (OS)
Part A and B: Progression free survival (PFS)
Part A and B: Time to progression (TTP)
Part A: Overall response rate (ORR)
Part B: Overall response rate (ORR)
Part B: Selection of Recommended Phase 2 Dose (RP2D)

Trial Safety

Phase-Based Safety

1 of 3

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

3 Treatment Groups

Part B: Ovarian Dose Expansion
1 of 3
Part A: Dose Escalation
1 of 3
Part C: ER+/HER2- BC Dose Expansion
1 of 3

Experimental Treatment

81 Total Participants · 3 Treatment Groups

Primary Treatment: Part B: Ovarian Dose Expansion · No Placebo Group · Phase 1 & 2

Part B: Ovarian Dose Expansion
Drug
Experimental Group · 1 Intervention: INX-315 · Intervention Types: Drug
Part A: Dose Escalation
Drug
Experimental Group · 1 Intervention: INX-315 · Intervention Types: Drug
Part C: ER+/HER2- BC Dose Expansion
Drug
Experimental Group · 1 Intervention: INX-315 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 36 months

Who is running the clinical trial?

Incyclix BioLead Sponsor

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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

Frequently Asked Questions

Is there an opportunity to join this clinical research at the current moment?

"Affirmative. According to the clinicaltrials.gov portal, this medical trial is presently enrolling 81 individuals from a single site. The initial post for this study was created on March 28th 2023 and it has since been updated with new information that same day." - Anonymous Online Contributor

Unverified Answer

Could you tell me the aggregate number of individuals involved in this trial?

"Indeed, data hosted on clinicaltrials.gov verifies that this medical research is currently enlisting volunteers. The study was initially listed in the public domain on March 28th 2023 and has since been updated once more to reflect its current recruitment status. As of now, 81 participants will be accepted at a single site." - 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.