An Open-label Study of ALPN-202 in Subjects With Advanced Malignancies

Phase 1

Terminated

• Conditions: Advanced Solid Tumor; Lymphoma
• Interventions: Drug: ALPN-202

• Registration Number: NCT04186637
• Lead Sponsor: Alpine Immune Sciences, Inc.

Brief Summary

This is a cohort-based, open-label dose escalation and expansion study in adults with advanced solid tumors or lymphoma, refractory or resistant to standard therapy, or without available standard or curative therapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-27
• Study First Submitted QC: 2019-12-02
• Study First Posted: 2019-12-05
• Study Start: 2020-06-02
• Primary Completion: 2022-11-09
• Study Completion: 2023-02-28
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-02
• Last Update Posted: 2023-06-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

1. Adult 18 to 75 years old at screening

2. Pathologically-confirmed, locally advanced or metastatic unresectable solid tumor of an acceptable histology

   Part A (Dose Escalation)

   1. that is refractory or resistant to standard therapy, including checkpoint inhibitor(s) if approved
   2. or for which standard or curative therapy is not available

   Part B (Dose Expansion)

   1. metastatic cutaneous melanoma
   2. PD-L1-positive cancers (other than cutaneous melanoma or renal cell carcinoma)
   3. metastatic renal cell carcinoma

3. Protocol-defined measurable disease

4. Available tumor biopsy representative of current disease

5. ECOG performance status grade 0-2

6. Life expectancy of ≥ 3 months

7. Recovery to ≤ Grade 1 for any non-laboratory toxicity resulting from previous anticancer therapy prior to first dose of ALPN-202 (except alopecia, hearing loss, ≤ Grade 2 neuropathy or endocrinopathy managed with replacement therapy)

8. Adequate baseline hematologic, renal, and hepatic function

Key

Exclusion Criteria

1. History of ≥ Grade 3 immune-related adverse event leading to treatment discontinuation

2. Active or prior pneumonitis or interstitial lung disease

3. Presence of any active central nervous system metastases

4. Prior organ allograft or allogeneic hematopoietic stem cell transplantation

5. Any serious or uncontrolled health condition, which, in the opinion of the Investigator, would place the subject at undue risk from the study, impair the ability of the subject to receive protocol specified therapy, or interfere with the interpretation of study results.

6. Receipt of any protocol-restricted therapy within the timeframes indicated:

   1. PD-L1 inhibitors: 5 half-lives (e.g., atezolizumab, 135 days; avelumab, 31 days; durvalumab, 85 days)
   2. Chemotherapy, small molecule anticancer agents (e.g., kinase inhibitors), or radiation: 2 weeks
   3. Other monoclonal antibodies, antibody-drug conjugates, bispecific antibodies, antibody like drugs, cytokines, cell therapies, or radioimmunoconjugates: 4 weeks

7. Any active, known, or suspected autoimmune disease

8. Systemic treatment with corticosteroids (> 10 mg/day prednisone) or other immunosuppressive medication

9. Any second malignancy active within the previous 3 years

10. Active infection requiring therapy at the time of the first dose of ALPN-202.

11. Known seropositivity for or active infection by human immunodeficiency virus, hepatitis B or C.

12. Known allergies, hypersensitivity, or intolerance to ALPN-202 or excipients in the drug product formulation.

13. History of Grade 4 infusion-related, anaphylactic or allergic reaction to any previous Fc-based protein therapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose escalation and expansion	ALPN-202	ALPN-202

Primary Outcome Measures

Name	Time	Method
Adverse Events	Up to 30 days after last dose of study drug	Type, incidence, and severity of adverse events as assessed by CTCAE

Secondary Outcome Measures

Name	Time	Method
Objective response	Up to 30 days after last dose of study drug	Best observed objective responses as assessed by RECIST for solid tumors, or Lugano for lymphoma

Trial Locations

Locations (10)

Investigational Site (004); 🇺🇸 Scottsdale, Arizona, United States

Investigational Site (003); 🇺🇸 New Haven, Connecticut, United States

Investigational Site (007); 🇺🇸 Lafayette, Indiana, United States

Investigational Site (006); 🇺🇸 Louisville, Kentucky, United States

Investigational Site (001); 🇺🇸 Grand Rapids, Michigan, United States

Investigational Site (009); 🇺🇸 Portland, Oregon, United States

Investigational Site (008); 🇺🇸 Pittsburgh, Pennsylvania, United States

Investigational Site (102); 🇦🇺 Perth, Nedlands, Australia

Investigational Site (101); 🇦🇺 Melbourne, Victoria, Australia

Investigational Site (103); 🇦🇺 Melbourne, Victoria, Australia