CBX-12 for Small Cell Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
NEXT Oncology, Austin, TXSmall Cell Lung Cancer+11 MoreCBX-12 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug, CBX-12, on people with cancer that has spread or returned after treatment. The goal is to see if it is safe and what side effects it has.

Eligible Conditions
  • Small Cell Lung Cancer
  • Solid Tumors, Adult
  • Ovarian Cancer
  • Breast Cancer
  • Colorectal Cancer
  • Pancreatic Cancer
  • Appendiceal Cancer
  • Non-Small Cell Lung Cancer
  • Stomach Cancer
  • Esophageal Cancer
  • Bladder Cancer
  • Sarcoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

5 Primary · 10 Secondary · Reporting Duration: 15 months

15 months
Phase 1: Recommended Phase 2 Dose for Daily x 3 every 3 weeks schedule of CBX-12
Phase 1: Recommended Phase 2 Dose for Daily x 5 every 3 weeks schedule of CBX-12
Phase 1: Recommended Phase 2 Dose for Once Weekly schedule of CBX-12
5 days
Apparent Volume of Distribution at Steady State (Vss) CBX-12
Area under the curve from 0-24 hours of CBX-12
Clearance (CL) of CBX-12
Half-life of CBX-12
Maximum concentration of CBX-12
Time to maximum concentration of CBX-12
Month 6
Duration of Response (DoR)
Phase 1: Incidence of treatment-emergent adverse events (TEAEs)
Phase 1: ORR
Phase 2: Incidence of TEAEs
Phase 2: Overall response rate (ORR)
Progression-free Survival (PFS)

Trial Safety

Safety Progress

1 of 3

Trial Design

5 Treatment Groups

Phase 1 Dose Escalation (Daily Dosing x 5)
1 of 5
Phase 1 Dose Escalation (Once Weekly Dosing )
1 of 5
Phase 2 Small Cell Lung Cancer Expansion Cohort
1 of 5
Phase 1 Dose Escalation (Daily Dosing x 3)
1 of 5
Phase 2 Ovarian Cancer Expansion Cohort
1 of 5

Experimental Treatment

112 Total Participants · 5 Treatment Groups

Primary Treatment: CBX-12 · No Placebo Group · Phase 1 & 2

Phase 1 Dose Escalation (Daily Dosing x 5)
Drug
Experimental Group · 1 Intervention: CBX-12 · Intervention Types: Drug
Phase 1 Dose Escalation (Once Weekly Dosing )
Drug
Experimental Group · 1 Intervention: CBX-12 · Intervention Types: Drug
Phase 2 Small Cell Lung Cancer Expansion Cohort
Drug
Experimental Group · 1 Intervention: CBX-12 · Intervention Types: Drug
Phase 1 Dose Escalation (Daily Dosing x 3)
Drug
Experimental Group · 1 Intervention: CBX-12 · Intervention Types: Drug
Phase 2 Ovarian Cancer Expansion Cohort
Drug
Experimental Group · 1 Intervention: CBX-12 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 15 months

Who is running the clinical trial?

Cybrexa TherapeuticsLead Sponsor
Chief Medical OfficerStudy DirectorCybrexa Therapeutics
113 Previous Clinical Trials
19,870 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

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Frequently Asked Questions

How many participants has the study recruited thus far?

"Affirmative. According to clinicaltrials.gov, this research program is enrolling patients at 4 distinct locations and the study has been active since May 3rd 2021. 112 individuals are eagerly sought after by researchers involved in the trial." - Anonymous Online Contributor

Unverified Answer

Is the clinical trial for this study being administered widely across North America?

"Presently, this trial is being run in 4 different sites located in Austin, San Antonio and New Haven among other places. Participants should select the closest clinical centre to reduce travel inconveniences." - Anonymous Online Contributor

Unverified Answer

What is the primary purpose of this research endeavor?

"This trial will span 15 months and the primary outcome is to be evaluated by measuring overall response rate (ORR). The secondary outcomes are Area under the Curve from 0-24 hours of CBX-12, Clearance (CL) of CBX-12, and Maximum concentration of CBX-12 as defined through PK Analysis." - Anonymous Online Contributor

Unverified Answer

Are there opportunities to join the research team of this experiment?

"Affirmative, the information found on clinicaltrials.gov suggests that this investigation is presently enrolling participants. This clinical trial was initially uploaded on May 3rd 2021 and recently modified on May 9th 2022. The research requires 112 individuals from 4 various sites to take part in it." - 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.