First-In-Human Study in Participants With Advanced Solid Tumors
ConditionAdvanced Solid Tumors
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChengdu Kanghong Biotech Co., Ltd.
About this trial
A Phase 1 Study of KH815 for Injection to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity in Patients with Advanced Solid Tumors
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed, written IRB-approved Informed Consent.
Male or female.
Aged 18 ~ 75 years.
Life expectancy of at least 3 months.
Disqualifiers
Pregnant or lactating women.
Major surgery within 4 weeks or will be expected to require major surgical treatment during the study period.
Radical radiotherapy or chest palliative radiotherapy within 4 weeks, or palliative radiotherapy at any other sites except chest within 2 weeks.
Antibody-based anti-cancer therapies, macromolecular protein products or cytotherapies within 4 weeks.
Trial design
Design model
Sequential
Treatments tested in this trial
KH815 for injection
DrugKH815 for injection is a dual-payload Antibody Drug Conjugate (ADC) targeting TROP2 antigens.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: KH815 for InjectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maximum Tolerated Dose (MTD)
To determine the maximum tolerated dose (MTD)
Time frame
Postdose of last participant up to 12 months2
Dose Limiting Toxicities (DLTs)
To determine the Dose Limiting Toxicities (DLTs).
Time frame
Baseline up to 21 days after the first dose3
Recommended Doses for Expansion (RDEs)
To determine the recommended doses for expansion (RDEs).
Time frame
Postdose of last participant up to 12 monthsSecondary outcomes
1
Cmax
To characterize the Cmax of KH815-ADC, KH815 TAB, free Drug-E payload and free Drug-T payload.
Time frame
Post last dose up to Day 602
Tmax
To characterize the Tmax of KH815-ADC, KH815 TAB, free Drug-E payload and free Drug-T payload.
Time frame
Post last dose up to Day 603
AUC0-t
To characterize the AUC0-t of KH815-ADC, KH815 TAB, free Drug-E payload and free Drug-T payload.
Time frame
Post last dose up to Day 604
AUCtau
To characterize the AUCtau of KH815-ADC, KH815 TAB, free Drug-E payload and free Drug-T payload.
Time frame
Post last dose up to Day 60Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: