A Study of TAK-853 in Adult Participants With Folate Receptor Alpha-Positive Advanced Ovarian Cancer And Other Solid Tumors

NCT06390995 | Active Not Recruiting Phase 1

• 2 other identifiers: TAK-853-1501jRCT2031240057
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 20

Brief Summary

The main aim of this study are to check for side effects from TAK-853, check how much TAK-853 participants can receive without getting side effects from it, check how well TAK-853 controls symptoms, and to check how much TAK-853 stays in their blood over time. The study will be conducted in two phases including Phase 1 Part and Phase 2 Part. In Phase 1 Part, the participants will stay in the hospital for 3 days at least after their 1st injection for some tests and to check for any side effects from their treatment. In Phase 2 Part, participants will visit their study hospital for multiple times. In both phases, the participants will receive TAK-853 on the first days of each 3-week cycle. The participant will be in the study for about 9 months in Phase 1 Part and for about 24 months in Phase 2 Part. The study doctors will check for side effects from the study treatments.

Conditions

Ovarian Cancer; Solid Tumors

Outcome Measures

Primary Outcomes (10)

• Phase 1 Part: Number of Participants with Dose-Limiting Toxicities (DLTs) in Cycle 1

  Toxicity will be evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0. DLT will be defined as any of the events specified in the protocol that are considered by the investigator to be at least possibly related to therapy with study medications.

  Up to 21 days

• Phase 1 Part: Number of Participants with Treatment-emergent Adverse Events (TEAEs)

  An adverse event (AE) means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. This includes any newly occurring event, or a previous condition that has increased in severity or frequency since the administration of study drug.

  1 year

• Phase 1 Part: Number of Participants with Grade 3 or Higher TEAEs

  A severity grade is defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. Grade 1 scales as Mild (asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2 scales as Moderate (minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living \[ADL\]); Grade 3 scales as Severe (severe or medically significant but not immediately life threatening hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL); Grade 4 scales as Life-threatening consequences, urgent intervention indicated, and Grade 5 scales as Death related to Adverse Event (AE).

  1 year

• Phase 1 Part: Number of Participants with Serious TEAEs

  An SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.

  1 year

• Phase 1 Part: Number of Participants with TEAEs Leading to Drug Discontinuation.

  1 year

• Phase 1 Part: Number of Participants with TEAEs Leading to Infusion Interrupted

  1 year

• Phase 1 Part: Number of Participants with TEAEs Leading to Dose Delayed

  1 year

• Phase 1 Part: Number of Participants with TEAEs Leading to Dose Reduction

  1 year

• Phase 1 Part: Number of Participants with Adverse Event of Clinical Interest (AECIs)

  An AE of clinical interest (serious or nonserious) is one of scientific and medical concern specific to the TAK-853, for which ongoing monitoring. Such events may require further investigation to characterize and understand them. AECIs for TAK-853 include: Ocular AEs, Pneumonitis, Peripheral neuropathy, and Infusion related reactions

  1 year

• Phase 2 Part: Overall Response Rate (ORR) Assessed by Investigator with RECIST 1.1

  The ORR is defined as the percentage of participants who achieved a confirmed Partial response (PR) or confirmed Complete response (CR) during the study using RECIST v1.1. Disease response criteria on RECIST 1.1 are following; Complete response (CR): Disappearance of all target lesions. Partial response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

  2 year

Secondary Outcomes (10)

• Phase 1 Part: Cmax: Maximum Observed Plasma Concentration

  1 year

• Phase 1 Part: AUC: Area Under the Plasma Concentration-Time Curve

  1 year

• Phase 1 Part: T1/2: Terminal Half-Life

  1 year

• Phase 1 Part: CL: Total Clearance

  1 year

• Phase 1 Part: Vss: Volume of Distribution at Steady State

  1 year

Study Arms (1)

Phase 1 Part and Phase 2 Part: TAK-853

EXPERIMENTAL

TAK-853, 6.0 mg/kg, injection, intravenously (IV), once every 3 weeks. Patients will continue to receive study drug until disease progression, unacceptable toxicity, withdrawal of consent, death, or until the sponsor terminates the study (whichever comes first).

Drug: TAK-853

Interventions

TAK-853 DRUG

TAK-853 intravenous injection

Also known as: Mirvetuximab Soravtansine

Phase 1 Part and Phase 2 Part: TAK-853

Eligibility Criteria

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

You may qualify if:

• Phase 1 part:
• Diagnosis, allowable prior therapy, and disease measurability requirements:
• All participants must have a pathologically documented, following advanced solid tumor known to express folate receptor alpha (FR alpha), that is resistant or refractory to standard treatment, for which no standard treatment is available, or the participant refuses standard therapy.
• Ovarian cancer
• Endometrial cancer
• Non-small cell lung cancer (NSCLC)
• Triple-negative breast cancer (TNBC)
• Cholangiocarcinoma
• Colorectal cancer (CRC)
• Gastro-esophageal adenocarcinoma Note: Participants with a solid tumor type other than the above will be eligible as long as there is prior documentation of tumor FR alpha expression.
• All participants without prior documentation of tumor FR alpha expression by immunohistochemistry (IHC) must be willing to provide an archival tumor tissue block or slides, or undergo procedure to obtain a new biopsy using a low risk, medically routine procedure for IHC confirmation of FR alpha positivity of \>=1% of viable tumor cells with membrane staining at \>=1+ intensity for entry into Phase 1 part
• There is no upper limit on the number of prior cytotoxic or targeted therapies the participant may have received. Participants may have received prior treatment with investigational compounds targeting folate receptor excluding MIRV.
• Participants must have measurable or non-measurable disease (such as large abdominal masses that cannot be accurately measured) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
• Participant must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
• Time from Prior Therapy:

You may not qualify if:

• Participants must have progressed radiographically on or after their most recent line of therapy
• Participants must be willing to provide an archival tumor tissue block or slides, or undergo procedure to obtain a new biopsy using a low risk, medically routine procedure for IHC confirmation of FR alpha expression (reported as "positive") as defined by the Ventana FOLR1 Assay. Tumors must be confirmed FR alpha-high as defined by FR alpha positivity of \>=75% of viable tumor cells with membrane staining at \>=2+ intensity for entry into the Phase 2.
• Participants must have at least one lesion that meets the definition of measurable disease by RECIST v1.1 criteria (radiologically measured by the Investigator).
• Participants must have received at least 1 but no more than 3 prior systemic lines of anticancer therapy, and for whom single-agent therapy is appropriate as the next line of treatment:
• a. Neoadjuvant +- adjuvant considered one line of therapy b. Maintenance therapy (e.g., bevacizumab, poly-ADP ribose polymerase \[PARP\] inhibitors) will be considered as part of the preceding line of therapy (i.e., not counted independently) c. Therapy changed due to toxicity in the absence of progression will be considered as part of the same line (i.e., not counted independently) d. Hormonal therapy will be counted as a separate line of therapy unless it was given as maintenance
• Participant must have an ECOG PS of 0 or 1
• Time from prior therapy:
• Systemic antineoplastic therapy (5 half-lives or 4 weeks, whichever is shorter)
• Focal radiation completed at least 2 weeks prior to first dose of study drug
• Participants must have stabilized or recovered (Grade 1 or baseline) from all prior therapy-related toxicities
• Major surgery must be completed at least 4 weeks prior to first dose and the participant must have recovered or stabilized from the side effects of prior surgery
• Participants must have adequate hematologic, liver, and kidney functions defined as:
• ANC \>= 1.5\* 10\^9/L (1,500/microliter) without G-CSF in the prior 10 days or long-acting WBC growth factors in the prior 20 days
• Platelet count \>= 100\* 10\^9/L (100,000/microliter) without platelet transfusion in the prior 10 days
• Hemoglobin \>= 9.0 g/dL without PRBC transfusion in the prior 21 days

Sponsors & Collaborators

• Takeda: lead

Study Sites (20)

Aichi Cancer Center

Nagoya, Aichi-ken, Japan

Location

Jikei University Kashiwa Hospital

Kashiwa, Chiba, Japan

Location

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Location

Shikoku Cancer Center

Matsuyama, Ehime, Japan

Location

Kurume University Hospital

Kurume, Fukuoka, Japan

Location

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Location

Sapporo Medical University Hospital

Sapporo, Hokkaido, Japan

Location

Hyogo Cancer Center

Akashi, Hyōgo, Japan

Location

Iwate Medical University Hospital

Shiwa-gun, Iwate, Japan

Location

Tohoku University Hospital

Sendai, Miyagi, Japan

Location

Saitama Medical University International Medical Center

Hidaka, Saitama, Japan

Location

Shizuoka Cancer Center

Nakatogari, Shizuoka, Japan

Location

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Location

Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, Japan

Location

The Jikei University Hospital

Minato-ku, Tokyo, Japan

Location

Keio University Hospital

Shinjuku-ku, Tokyo, Japan

Location

Chiba University Hospital

Chiba, Japan

Location

Kyoto University Hospital

Kyoto, Japan

Location

Okayama University Hospital

Okayama, Japan

Location

Osaka International Cancer Institute

Osaka, Japan

Location

Related Links

• To obtain more information on the study, click here/on this link

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

mirvetuximab soravtansine

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: April 30, 2024
• Study Start: May 20, 2024
• Primary Completion: April 16, 2025
• Study Completion (Estimated): March 19, 2027
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

JP (20)