UPCC 22925 A Phase Ia/Ib Open-label, Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of ROSE12 as a Single Agent and in Combination With Other Anti-tumor Agents in Patients With Locally Advanced or Metastatic Solid Tumors

Study on Safety and Pharmacokinetics of an Investigational Medication for Advanced Solid Tumors

Enrolling By Invitation
18 years or above
All
Phase 1
209 participants needed
1 Location

Brief description of study

This is a Phase Ia/Ib open-label, dose-escalation study to evaluate the safety and pharmacokinetics of ROSE12 as a single agent and in combination with other anti-tumor agents in patients with locally advanced or metastatic solid tumors. The study will consist of three parts: a dose-escalation part, a biopsy part (the part to evaluate biomarkers), and an expansion part.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Solid Tumor
  • Age: 18 years or above
  • Gender: All

  • Age >= 18 years at time of signing informed consent form (ICF)
    • Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1
    • Adequate hematologic and end-organ function
    • Life expectancy >= 12 weeks
    • Patients with histologic documentation of locally advanced, or metastatic solid tumor
    • [Dose-escalation Parts and Biopsy Parts]Refractory or resistant to standard therapies or standard therapies are not available
    • [Dose-escalation Parts and Expansion Part] Patients with confirmed availability of fresh tumor or representative tumor specimens
    • [Biopsy Parts] Patients with accessible lesion(s)
    • [Expansion Parts] Patients with ICI (immune checkpoint inhibitor)-refractory 2L-3L NSCLC (non-small-cell lung cancer) and 3L+ CRC (colorectal cancer)

Exclusion Criteria:

  • Clinically significant cardiovascular or liver disease
  • Treatment with investigational therapy and anti-cancer therapy within 28 days prior to initiation of study drug
  • Any history of an immune-mediated Grade 4 adverse event attributed to prior cancer immunotherapy (other than asymptomatic elevation of serum amylase or lipase).
  • All imAEs from prior cancer immunotherapy (other than endocrinopathy managed with replacement therapy, stable vitiligo or stable alopecia) that have not resolved completely to baseline.
  • Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1 except for alopecia, vitiligo, or endocrinopathy managed with replacement therapy
  • Primary central nervous system (CNS) malignancy, untreated CNS metastases requiring any anti-tumor treatment, or active CNS metastases
  • Uncontrolled tumor-related pain
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
  • Active or history of clinically significant autoimmune disease
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.

[Expansion Part]

  • Prior treatment with investigational product which has MoA of Treg depletion
  • Malignancies other than disease under study within 5 years prior to Cycle 1 Day 1

This study investigates the safety and pharmacokinetics of an investigational medication, ROSE12, in patients with locally advanced or metastatic solid tumors. The study is conducted in three parts: a dose-escalation part to determine the safe dose, a biopsy part to evaluate biomarkers, and an expansion part to further assess the effects of the medication.

Participants will receive the investigational medication alone or in combination with other anti-tumor agents. The study includes procedures such as dose escalation to find the optimal dose and biopsies to study tumor samples. Pharmacokinetics will also be closely monitored.

  • Who can participate: Adults aged 18 years or older with locally advanced or metastatic solid tumors can participate. Key eligibility includes having a good performance status, adequate organ function, and a life expectancy of at least 12 weeks. Participants must have tumors that are resistant to standard therapies or where such therapies are unavailable.
  • Study details: Monitoring will include assessing how the body processes the drug.
Updated on 28 Jul 2026. Study ID: 25-2094
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Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.

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