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Closed (no longer recruiting)Last updated: 2 February 2024

This phase I study is evaluating how safe and effective a combination of two new cancer drugs (YH002 and YH001) are in people with advanced solid cancersA Multicenter, Open-label, Phase I Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of YH002 in Combination With YH001 in Subjects With Advanced Solid Tumors

Clinical summary

Summary

This study has two parts. In the Dose Escalation Part, a traditional 3+3 dose escalation algorithm will be used to identify the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D). In the Dose Expansion part, one selected dose will be expanded to enrol an additional 20 participants. The participants will be divided into two groups: A and B. Group A will receive YH002 on CnD1,YH001 on CnD8,Q3W. Group B will receive YH002 and YH001 on same day,Q3W.

Conditions

This trial is treating patients with advanced solid cancers.

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

More information

Trial Identifiers

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Trial sponsor

Eucure (Beijing) Biopharma Co., Ltd

Scientific Title

A Multicenter, Open-label, Phase I Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of YH002 in Combination With YH001 in Subjects With Advanced Solid Tumors

Eligibility

Inclusion

To be eligible for study entry patients must satisfy all of the following criteria:

  1. Subjects must have the ability to understand and willingness to sign a written informed consent document.
  2. Subjects must have histologically advanced or cytologically confirmed solid tumor and and must have at least 1 unidimensional measurable lesion by RECIST 1.1.
  3. Subjects have progressed on after treatment with at least one standard therapy, or intolerant of the standard therapy, or no standard therapy accessible to the patients due to any reason.
  4. Subjects must be age 18 to 80 years of age at the time of screening.
  5. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  6. Life expectancy ≥3 months based on investigator's judgement.
  7. Subjects have adequate bone marrow and other organ function at the screening visit.
  8. Women of reproductive potential must have negative serum beta human chorionic gonadotropin (β -HCG) pregnancy test within 7 days of the first dosing. Women of reproductive potential are those who have not been post-menopausal for at least 12 months or who have not undergone bilateral tubal occlusion, hysterectomy, or bilateral salpingectomy.

Exclusion

Subjects who meet any of the following criteria cannot be enrolled:

  1. Subjects have another active invasive malignancy within 5 years.
  2. Previous exposure to TNFR such as anti-OX40 antibodies.
  3. Subjects must not have received any anticancer therapy or another investigational agent within the shorter of 4 weeks or 5 half-lives before the first dose of the study treatment(subject to the longer one).
  4. Continuance of toxicities due to prior radiotherapy or chemotherapy agents that have not recovered to ≤ Grade 1 per CTCAE 5.0, except alopecia ≤ Grade 2.
  5. Primary central nervous system (CNS) malignancies or symptomatic CNS metastases.
  6. Subjects must not have a known or suspected history of an autoimmune disorder, including but not limited to inflammatory bowel disease, celiac disease, Wegner syndrome, Hashimoto syndrome, systemic lupus erythematosus, scleroderma, sarcoidosis, or autoimmune hepatitis, within 3 years of the first dose of study treatment.
  7. Clinically uncontrolled intercurrent illness, including but not limit to an ongoing active infection, active coagulopathy, uncontrolled diabetes (blood glucose > 250 mg/dl), uncontrolled pleural and peritoneal effusion, psychiatric illness that would limit compliance with the study requirements and other serious medical illnesses requiring systemic therapies
  8. Subjects must not have active infection of human immunodeficiency virus, hepatitis B, hepatitis C or Covid-19.

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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