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An Open-Label, Multicenter, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Preliminary Antitumor Activity of HH160 Alone or in Combination With Other Antitumor Agents in Patients With Advanced or Metastatic Solid Tumors
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
This study is evaluating the safety, side effects, how the body processes HH160, and its early anticancer activity when given alone or with other cancer treatments in participants with advanced solid tumors. The study will also identify the recommended dose for future studies. The trial includes two phases and is expected to last about 4 years, with treatment and follow-up lasting approximately 6-12 months each.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Adults aged 18 to 75 years with signed informed consent.
• Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status of 0 or 1 with life expectancy ≥ 12 weeks.
• Adequate organ function based on protocol-specified laboratory criteria.
Locations
Other Locations
Australia
Tasman Health Care
RECRUITING
Southport
Calvary Mater Newcastle
RECRUITING
Waratah
China
Shandong Tumour Hospital Dongyuan Unit
RECRUITING
Jinan
Contact Information
Primary
Medical Officer
zhouxin@hhhbio.com
+86-010-80766688
Backup
Study Director
clinicaltrials@beonemed.com
1-877-828-5568
Time Frame
Start Date:2026-06-11
Estimated Completion Date:2028-08
Participants
Target number of participants:299
Treatments
Experimental: Phase 1a Part 1 : Dose Escalation
Participants with advanced solid tumors will receive escalating doses of HH160
Experimental: Phase 1a Part 2: Safety Expansion
Participants with selected advanced or metastatic solid tumors will receive HH160 at dose levels determined to be tolerable during dose escalation to further evaluate safety and tolerability.
Experimental: Phase 1b: Dose Expansion
Additional participants with selected advanced or metastatic solid tumors will receive HH160 alone or in combination with chemotherapy at selected expansion dose levels and schedules identified during phase 1a.