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Dose Escalation - HFB200603 in combination with tislelizumab for Non-Small Cell Lung Cancer

New Experimental Therapeutics of Virginia - NEXT Oncology, Fairfax, VA
Non-Small Cell Lung Cancer+4 More ConditionsHFB200603 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial tests the safety and effectiveness of two cancer treatments, HFB200603 and tislelizumab, in patients with advanced cancers.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Melanoma
  • Stomach Cancer
  • Kidney Cancer
  • Colorectal Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

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Escalation Cohort
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Single-agent KFA115

Study Objectives

7 Primary · 9 Secondary · Reporting Duration: Baseline to disease progression or death, whichever occurs first, assessed up to 3 years

Year 3
Disease Control Rate (DCR) as determined by RECIST 1.1 and iRECIST
Objective Response Rate (ORR) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and immune-RECIST (iRECIST)
Year 3
Progression Free Survival (PFS) as determined by RECIST 1.1 and iRECIST
Year 3
Number of participants with AEs
Number of participants with changes in electrocardiogram (ECG)
Number of participants with changes in laboratory values
Number of participants with changes in tolerability (dose interruptions and dose intensity)
Number of participants with changes in vital signs
To determine a Recommended Phase 2 Dose (RP2D) during Dose Expansion
Year 3
Area under the concentration versus time curve (AUC)
Maximum serum concentration (Cmax)
Minimum serum concentration (Cmin)
Serum concentration for measurement of anti-HFB200603 antibodies
Terminal half-life (T1/2)
Year 3
Duration of Response (DOR) as determined by RECIST 1.1 and iRECIST
Day 21
Number of participants with adverse events (AEs) meeting protocol-defined Dose-Limiting Toxicity (DLT) criteria during Dose Escalation

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

1
Dose Escalation
1
Escalation Cohort
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Single-agent KFA115

Awards & Highlights

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

Trial Design

4 Treatment Groups

Dose Escalation - HFB200603 in combination with tislelizumab
1 of 4
Dose Escalation - HFB200603 monotherapy
1 of 4
Dose Expansion - HFB200603 monotherapy (optional)
1 of 4
Dose Expansion - HFB200603 in combination with tislelizumab
1 of 4

Experimental Treatment

83 Total Participants · 4 Treatment Groups

Primary Treatment: Dose Escalation - HFB200603 in combination with tislelizumab · No Placebo Group · Phase 1

Dose Escalation - HFB200603 in combination with tislelizumabExperimental Group · 2 Interventions: HFB200603, Tislelizumab · Intervention Types: Drug, Drug
Dose Escalation - HFB200603 monotherapy
Drug
Experimental Group · 1 Intervention: HFB200603 · Intervention Types: Drug
Dose Expansion - HFB200603 monotherapy (optional)
Drug
Experimental Group · 1 Intervention: HFB200603 · Intervention Types: Drug
Dose Expansion - HFB200603 in combination with tislelizumabExperimental Group · 2 Interventions: HFB200603, Tislelizumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tislelizumab
2018
Completed Phase 3
~1930

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to disease progression or death, whichever occurs first, assessed up to 3 years

Who is running the clinical trial?

HiFiBiO TherapeuticsLead Sponsor
4 Previous Clinical Trials
298 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

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

Frequently Asked Questions

Has Dose Expansion - HFB200603 monotherapy (optional) obtained clearance from the FDA?

"Due to the limited clinical data concerning Dose Expansion - HFB200603 monotherapy (optional), our team at Power rated its safety a 1 out of 3." - Anonymous Online Contributor

Unverified Answer

Is enrollment currently available for this research project?

"As seen on clinicaltrials.gov, this medical trial has commenced participant recruitment since April 1st 2023 and was last modified a little over three weeks ago." - Anonymous Online Contributor

Unverified Answer

To what extent has the trial been populated with participants?

"Affirmative. Information posted to clinicaltrials.gov confirms that the recruitment for this trial is ongoing, beginning April 1st 2023 and last edited on 4/25/2023. The aim is to enrol 83 individuals from a single medical centre." - 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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