A Study of HY-0102 in Patients With Advanced Solid Tumors

NCT06094777 | Unknown Phase 1

• 1 other identifier: YL-0102-02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase 1 open label multicenter study to evaluate the maximum tolerance, safety, tolerance and PK of HY-0102 administered intravenously (IV) once every two weeks in patients with advanced solid tumors, so as to confirm the recommended phase 2 dose of HY-0102 and obtain the preliminary efficacy information of patients with advanced solid tumors.

Conditions

Advanced Solid Tumor

Keywords

Urothelial carcinoma; Colorectal cancer; Pancreatic cancer; NKG2A; Humanized monoclonal antibody

Outcome Measures

Primary Outcomes (5)

• Occurrence of drug limited toxicities (DLTs)

  To assess by the occurrence of Drug Limited Toxicities (DLTs)

  From Time of First dose through DLT observation period, 28 days

• Incidence of Treatment-emergent adverse event (TEAEs) and serious adverse events (SAEs)

  To assess by the occurrence of Treatment-emergent adverse event (TEAEs) and serious adverse events (SAEs)

  From the start of treatment until up to 30(±7) days after the last dose of study drug

• Number of patients with changes in laboratory parameters from baseline

  To assess safety of HY-0102

  From the start of treatment until up to 30(±7) days after the last dose of study drug

• Number of patients with changes in electrocariogram (ECG) from baseline

  To assess safety of HY-0102

  From the start of treatment until up to 30(±7) days after the last dose of study drug

• Number of participants with changes in clinically significant vital sign from baseline

  To assess safety of HY-0102

  From the start of treatment until up to 30(±7) days after the last dose of study drug

Secondary Outcomes (12)

• ORR (confirmed complete or partial response)

  FU period/EOS visits every 3 months (± 14 days) after the EOT visit for 12 months

• DCR (confirmed response or stable disease lasting for at least 6 months)

  FU period/EOS visits every 3 months (± 14 days) after the EOT visit for 12 months

• Duration of Response (DoR)

  FU period/EOS visits every 3 months (± 14 days) after the EOT visit for 12 months

• Progression Free Survival (PFS)

  FU period/EOS visits every 3 months (± 14 days) after the EOT visit for 6 months

• Cmax (Maximum observed serum concentration) of HY-0102

  From first dose through 30days(±7) days after the last dose of study medication

Study Arms (1)

HY-0102

EXPERIMENTAL

Dose Escalation(Standard 3+3 Dose escalation) Cohort 1: 5 mg/kg Q2W HY-0102 ivgtt Duration: 24w,DLT observation period: 28 days. Cohort 2: 10 mg/kg Q2W HY-0102 ivgtt Duration: 24w,DLT observation period: 28 days. Cohort 3: 15 mg/kg Q2W HY-0102 ivgtt Duration: 24w,DLT observation period: 28 days. Dose Expansion Within the MTD and sub-MTD dose groups, select 1-2 doses for dose expansion, including approximately 30-40 cases of tumor types that have demonstrated preliminary efficacy in the early escalation phase. Conduct safety, tolerability, and preliminary anti-tumor efficacy evaluations to provide a basis for the recommended phase II clinical dose (RP2D). PK studies will be conducted on 12 subjects in each dose group, including dose escalation trial cases.

Drug: HY-0102

Interventions

HY-0102 DRUG

Multiple dose cohorts, 60 minute IV infusion, every two weeks, 28 days as a cycle

HY-0102

Eligibility Criteria

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

You may qualify if:

• Demonstrated willingness to voluntarily provide a signed informed consent document.
• Male or female individuals aged ≥18 years.
• Advanced malignant solid tumor patients who have experienced treatment failure using established therapeutic methods, have no viable standard treatment options available, or are unable to tolerate standard therapy. (Preference will be given to patients with urothelial carcinoma, colorectal cancer, and pancreatic cancer)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Anticipated minimum survival duration of 3 months.
• Measurable or evaluable lesions detected by CT/MRI scans; participants in the dose expansion phase must have quantifiable lesions according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). Measurable lesions may also include those located in previously irradiated (or subjected to other local therapy) areas, demonstrating evident progression as confirmed by post-radiation therapy imaging.
• Participants must meet the following laboratory criteria with adequate organ and bone marrow function prior to enrollment:
• Considering potential interactions between the investigational drug and oral contraceptives, oral contraceptives should always be combined with alternative contraceptive methods. This requirement also applies to male participants with partners of childbearing potential, who must utilize condoms.
• Non-menopausal (non-treatment-related amenorrhea for ≥12 months) or non-sterilized female participants must obtain a negative serum pregnancy test result within 7 days prior to initiating the study drug.
• Women who have undergone tubal ligation or hysterectomy are exempt from contraception requirements.
• \. Participants must have sufficiently recovered from all acute toxicities resulting from previous treatment (recovery to Grade 1 or below), excluding alopecia, hyperpigmentation, peripheral neuropathy recovered to \<CTCAE Grade 2, and long-term toxicities caused by radiation therapy, at the discretion of the investigator.

You may not qualify if:

• Participants will be excluded if they meet any of the following criteria:
• Allergies or hypersensitivity to any component of the investigational product.
• Severe or uncontrolled cardiac diseases, congestive heart failure graded as III or IV according to the New York Heart Association (NYHA), unstable angina that cannot be controlled with medication, history of myocardial infarction within the previous 6 months, or severe arrhythmias requiring medication (excluding atrial fibrillation or paroxysmal supraventricular tachycardia).
• Active seizures requiring antiepileptic drugs, recent (\< 6 months) cerebrovascular accidents or transient ischemic attacks.
• Symptomatic brain metastases or untreated brain metastases meeting at least one of the following criteria:
• Requires the use of corticosteroids or dehydration therapy (excluding antiepileptic drugs after surgery or radiation therapy);
• Presents with clinically significant symptoms;
• Tumor stability lasting less than 4 weeks after radiation therapy or surgery.
• Requires oxygen therapy for daily activities; asthma requiring medical intervention with bronchodilators.
• Peripheral neuropathy of Grade ≥2.
• Received any chemotherapy, hormonal therapy, radiation therapy, immunotherapy, or biological therapy within 4 weeks prior to the first dose of the investigational treatment, or within 5 half-lives of the previous treatment, whichever is shorter. The following exceptions are allowed:
• Local topical or inhaled corticosteroids;
• Short-term (≤7 days) use of corticosteroids for prophylaxis or treatment of non-autoimmune allergy disorders;
• Local palliative radiation therapy for bone metastases.
• Underwent major surgery within 4 weeks prior to enrollment or has not fully recovered from previous surgery (definition of major surgery according to the "Management Measures for Clinical Application of Medical Technologies" implemented on May 1, 2009) or anticipates significant surgery within 28 days during the study.

Sponsors & Collaborators

• Shanghai YingLi Pharmaceutical Co. Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Transitional Cell; Colorectal Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Dingwei Ye, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dingwei Ye, PhD

CONTACT

13701663571; dwyeli@163.com

Jian Zhang, PhD

CONTACT

18017312991; syner2000@163.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: October 16, 2023
• First Posted: October 23, 2023
• Study Start: December 18, 2023
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 13, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)