First-In-Human Study in Participants With Advanced Solid Tumors

NCT06885645 | Not Yet Recruiting Phase 1

• 1 other identifier: KH815-30101
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

• Maximum Tolerated Dose (MTD)

  To determine the maximum tolerated dose (MTD)

  Postdose of last participant up to 12 months

• Dose Limiting Toxicities (DLTs)

  To determine the Dose Limiting Toxicities (DLTs).

  Baseline up to 21 days after the first dose

• Recommended Doses for Expansion (RDEs)

  To determine the recommended doses for expansion (RDEs).

  Postdose of last participant up to 12 months

Secondary Outcomes (7)

• Cmax

  Post last dose up to Day 60

• Tmax

  Post last dose up to Day 60

• AUC0-t

  Post last dose up to Day 60

• AUCtau

  Post last dose up to Day 60

• t1/2

  Post last dose up to Day 60

Study Arms (1)

KH815 for Injection

EXPERIMENTAL

Phase I: Dose Escalation Phase I part of the study:dose1-dose5 of KH815 for injection

Drug: KH815 for injection

Interventions

KH815 for injection DRUG

KH815 for injection is a dual-payload Antibody Drug Conjugate (ADC) targeting TROP2 antigens.

KH815 for Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed, written IRB-approved Informed Consent.
• Male or female.
• Aged 18 \~ 75 years.
• Life expectancy of at least 3 months.
• Histologically or cytologically confirmed advanced or unresectable solid tumors for wihch failure or difficult to be treated with standard therapies, or not suitable for standard therapies.
• Measurable disease by CT/MRI as defined in RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.

You may not qualify if:

• Pregnant or lactating women.
• Received cancer-directed therapy within the following timeframes:
• 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.
• Chemotherapy (including non-antibody based immunotherapy therapy) within 2 weeks (6 weeks for nitrosoureas or mitomycin C) or 5 times half life of the chemotherapeutic agent (whichever is longer).
• Any natural medicine with anti-tumor effect within 2 weeks.
• Tyrosine kinase inhibitor (TKI) treatment within 1 week.
• Received experimental drug therapy or participated in a clinical study of a medical device within 4 weeks prior to first infusion of KH815.
• Known history of unstable angina, myocardial infarction (MI), or congestive heart failure (CHF) (NYHA Class II-IV) within 6 months or clinically significant arrhythmia (other than stable atrial fibrillation or paroxysmal superventricular tachycardia) requiring anti-arrhythmia therapy
• Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) and/or diabetes (HbA1c ≥ 9.0%).
• Uncontrolled pleural effusion or pericardial effusion. Ascites requiring repeated drainage surgery (once a month or more frequently).
• Patients with moderate to severe respiratory dyspnea due to severe primary lung disease or complications of advanced malignancy \[rated as grade 3/4 by modified Medical Research Council (mMRC) scale\] (see Appendix 3), or requiring continuous oxygen therapy, or acute exacerbations of chronic obstructive pulmonary disease (AECOPD), or history of interstitial lung disease (ILD)/pneumonia, or ILD/ pneumonia that could not be ruled out on imaging during screening, or any autoimmune disease/connective tissue disease (e.g. Rheumatoid arthritis, Sjogren's syndrome, sarcoidosis) with lungs involvement.
• Grade ≥2 anorexia, nausea, vomiting, or diarrhea within 2 weeks prior to first infusion of KH815.

Sponsors & Collaborators

• Chengdu Kanghong Biotech Co., Ltd.: lead

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Fei Ma, Dr.

CONTACT

+86 10 87788114; drmafei@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 20, 2025
• Study Start: April 30, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share