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Clinical Trials List

Protocol NumberALKS 4230-001
NCT Number(ClinicalTrials.gov Identfier)NCT03861793

2020-05-18 - 2023-12-31

Others

Recruiting6

ICD-9239.8

Neoplasm of unspecified nature of other specified sites

A Phase 1/2 Study of ALKS 4230 Administered Subcutaneously as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors - ARTISTRY-2 (001)

  • Trial Applicant

    Syneos Health

  • Sponsor

    Alkermes, Inc.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Li-Yuan Bai Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yee Chao 無
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 鍾奇峰 無
Koo Foundation Sun Yat-Sen Cancer Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shang-Yin Wu 無
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shau-Hsuan Li Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Advanced Solid Tumors、non–small-cell lung cancer、squamous cell carcinoma of the head and neck、squamous tumor agnostic、hepatocellular carcinoma and small-cell lung cancer

Objectives

Primary Objectives • To characterize the safety and tolerability and to identify the RP2D of ALKS 4230 administered SC as lead-in monotherapy and in combination with pembrolizumab in subjects with advanced solid tumors (Phase 1) • To characterize the safety profile of SC ALKS 4230 at the RP2D in combination with pembrolizumab in subjects with advanced solid tumors (Phase 2) • To estimate the clinical activity of combination treatment with ALKS 4230 and pembrolizumab in terms of objective response rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines version 1.1 (Eisenhauer et al 2009) separately for NSCLC, squamous cell carcinoma of the head and neck (SCCHN), squamous tumor agnostic, hepatocellular carcinoma (HCC), and small-cell lung cancer (SCLC) (Phase 2) Secondary Objectives • To describe dose-limiting toxicity (DLT) for SC ALKS 4230 lead-in monotherapy (Phase 1) • To characterize the PK, clinical PD, and immunogenicity of SC ALKS 4230 as lead-in monotherapy (Phase 1) and in combination with pembrolizumab (Phase 1 and Phase 2) • To describe antitumor activity observed with SC ALKS 4230 as lead-in monotherapy and in combination with pembrolizumab (Phase 1) • To evaluate antitumor efficacy in subjects treated with SC ALKS 4230 in combination with pembrolizumab (Phase 2)

Test Drug

ALKS 4230

Active Ingredient

ALKS 4230

Dosage Form

injection

Dosage

1, 5, 15

Endpoints

Primary Outcome Measures :
Incidence of Adverse Events (AEs), and identify the RP2D of ALKS 4230 in Part A [ Time Frame: From time of initiation of therapy until 30 days after last dose of study drug, assessed up to 24 months ]
Includes AEs that are both serious and drug-related

Number of subjects experiencing AEs that are both serious and drug-related in Part B [ Time Frame: From time of initiation of therapy until 30 days after last dose of study drug, assessed up to 24 months ]
Includes AEs that are both serious and drug-related

Clinical Activity of combination treatment with ALKS 4230 and pembrolizumab in each Part B tumor type. [ Time Frame: From time of therapy until the date of first documented tumor progression, assessed up to 24 months ]
Overall Response rate (ORR) will be based on investigator review of radiographic and photographic images


Secondary Outcome Measures :
Proportion of subjects with objective evidence of Complete Response (CR)/immune CR (iCR) [ Time Frame: From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months ]
Overall response rate (ORR) will be based on investigator review of radiographic or photographic images

Proportion of subjects with objective evidence of Partial Response (PR)/immune PR (iPR) [ Time Frame: From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months ]
ORR will be based on investigator review of radiographic or photographic images

Duration of response in subjects with CR/iCR [ Time Frame: Time from the first documentation of complete response, measured approximately every 6 weeks, to the first documentation of objective tumor progression or death due to any cause (estimated up to 24 months) ]
CR/iCR duration

Duration of response in subjects with PR/iPR [ Time Frame: Time from the first documentation of complete response, measured approximately every 6 weeks, to the first documentation of objective tumor progression or death due to any cause (estimated up to 24 months) ]
PR/iPR duration

Non-progression for Part B [ Time Frame: Assessed up to 24 months ]
Time from first dose of SC ALKS 4230 to the time of progression or death

Overall survival for Part B [ Time Frame: Assessed up to 24 months ]
Time from first dose of SC ALKS 4230 to the time of death

Serum concentrations of ALKS 4230 will be determined at various time points [ Time Frame: From time of initiation of therapy until the last treatment cycle (each cycle is 21 days), assessed up to 24 months ]
Concentration vs time and standard pharmacokinetic (PK) parameters will be summarized by dose level

Serum will be assayed for the presence of anti-ALKS 4230 antibodies [ Time Frame: From time of initiation of therapy until the last treatment cycle (each cycle is 21 days), assessed up to 24 months ]
Results will be summarized by dose level

Immunophenotyping of peripheral blood mononuclear cells will be performed by flow cytometry at various time points [ Time Frame: From time of initiation of therapy until the last treatment cycle (each cycle is 21 days), assessed up to 24 months ]
Results will be summarized by dose level

Serum concentrations of proinflammatory cytokines will be assessed using a multiplex method at various time points [ Time Frame: From time of initiation of therapy until the last treatment cycle (each cycle is 21 days), assessed up to 24 months ]
Results will be summarized by dose level

Inclution Criteria

Inclusion Criteria:

For Phase I the subject has histological or cytological evidence of a solid tumor. For Phase II the subject must have 1 of the specified adult solid tumor types defined in the protocol
Subject must have at least one target lesion based on RECIST
Subject has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1
Subjects must have adequate liver function
Subjects must have adequate kidney function
Subjects must be recovered from the effects of any prior chemotherapy, immunotherapy, other prior systemic anticancer therapy, radiotherapy or surgery
Subjects who have received radiation therapy must wait at least 4 weeks after their last radiation treatment before enrollment into the study
Females of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment and on Day 1 before the first dose is administered
Subject will agree to follow contraceptive requirements defined in the protocol
Additional criteria may apply

Exclusion Criteria

Exclusion Criteria:

Subject is currently pregnant, planning to become pregnant, or breastfeeding
Subjects with an active infection or with a fever ≥ 38.5°C within 3 days of the first scheduled day of dosing for Cycle 1
Subjects with active or symptomatic central nervous system metastases are excluded. Subjects with central nervous system metastases are eligible for the study if the metastases have been treated by surgery and/or radiation therapy, the subject is off corticosteroids for at least 2 weeks, and the subject is neurologically stable
Subjects with known hypersensitivity to any components of ALKS 4230 or to pembrolizumab or any of its excipients
Subjects who require pharmacologic doses of systemic corticosteroids are excluded; replacement doses, topical, ophthalmologic, and inhalational steroids are permitted
Subjects who developed autoimmune disorders while on prior immunotherapy, including pneumonitis, nephritis, and/or neuropathy
Subjects with any other concurrent uncontrolled illness, including mental illness or substance abuse, which may interfere with the ability of the subjects to cooperate and participate in the study
The subject is known to be positive for human immunodeficiency virus (HIV), hepatitis B or C, or active tuberculosis, or has a known history of tuberculosis
Additional criteria may apply

The Estimated Number of Participants

  • Taiwan

    30 participants

  • Global

    257 participants

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