Health TrialsbyHealthPanel

First-In-Human Study of KHN922 for Injection

ConditionAdvanced Solid Tumors Cancer
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChengdu Kanghong Biotech Co., Ltd.

About this trial

A Phase 1/2 Study of KHN922 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 volunteers

Qualifiers

None

Disqualifiers

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.

Hormonal anti-tumor therapy within 2 weeks.

Trial design

Design model

Sequential

Treatments tested in this trial

  • KHN922 for injection

    Drug

    KHN922 for injection is a dual-payload Antibody Drug Conjugate (ADC) targeting HER3 antigens，intravenous (IV) administration every three weeks (D1) .

Treatment groups

276 Participants
are divided into 1 treatment group
Group A: Phase I KHN922 for InjectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose Limiting Toxicities (DLTs)

To evaluate the safety and tolerability of KHN922 to determine the dose and schedule to be used in phase 1

Time frame
At the end of Cycle 1 (each cycle is 21 days)
2

Objective Response Rate (ORR)

To evaluate the objective response rate (ORR) of KHN922 for injection when administered intravenously (IV) as monotherapy at the RP2D to patients with advanced solid tumors.

Time frame
up to 12 months

Secondary outcomes

1

Maximum plasma concentration (Cmax)

To evaluate the systemic pharmacokinetics of KHN922 in subjects.

Time frame
through study completion, an average of 1 year
2

ADA prevalence and incidence

To assess the prevalence and incidence of anti-drug antibody (ADA) of KHN922

Time frame
through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chengdu Kanghong Biotech Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: