Trial Outcomes & Findings for A Study of TAK-103 in Adult With Solid Tumors (NCT NCT05164666)

Participants took part in the study at 2 investigative sites in Japan from 05 January 2022 to 22 February 2025.

A total of 20 participants were screened, of which 18 participants were screen failures and the remaining 2 were enrolled in the study. The study was terminated early by the sponsor due to a business decision unrelated to patient safety.

A Study of TAK-103 in Adult With Solid Tumors

DLTs were evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Any Grade 3 or higher toxicities that were considered by the investigator to be at least possibly related to therapy with TAK-103 during the 28 days immediately after infusion of TAK-103 and, any adverse events (AEs) requiring endotracheal intubation or tracheostomy were considered as DLTs.

An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug. An AE can be any unfavourable and unintended sign (including physical examinations, vital signs, electrocardiogram (ECG), laboratory assessment findings), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. TEAEs were defined as AEs that newly occurred or worsened on or after the start of study product administration.

In this study, immune effector cell-associated neurotoxicity syndrome (ICANS), cytokine release syndrome (CRS), hemophagocytic lymphohistiocytosis (HLH), macrophage activation syndrome (MAS), and tumor lysis syndrome (TLS) were predefined as AECIs. CRS and ICANS were evaluated according to American Society for Transplantation and Cellular Therapy (ASTCT) consensus. For management of HLH and MAS, CARTOX (CAR-T-cell-therapy-associated TOXicity) recommendations were used.

ORR was defined as the percentage of participants whose best overall response was complete response (CR) or partial response (PR) as determined by the investigator per Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1. Complete Response (CR): Disappearance of all target lesions (TL) and non-target lesions and normalization of tumor marker level. Partial response (PR): At least a 30 percent (%) decrease in the sum of the longest diameter (LD) of TL, taking as reference the baseline sum LD.

ORR was defined as the percentage of participants whose best overall response was immune complete response (iCR) or immune partial response (iPR) as determined by the investigator per iRECIST. Immune Complete Response (iCR): Disappearance of all TL and Non-TL. All lymph nodes must be non-pathological in size (less than \[\<\]10 millimeters \[mm\] in short axis diameter \[SAD\]). Immune Partial Response (iPR): Tumor load of the TL is reduced by less than or equal to (=\<) 30% compared to the baseline, or in the case of complete remission of the TL, when one or more, non-TL can still be distinguished. Immune Stable Disease (iSD), which is to be determined if the criteria of iCR or iPR are not met and no tumor progression is present.

DCR was defined as the percentage of participants whose best overall response was CR, PR and stable disease (SD) or better as determined by the investigator per RECIST version 1.1. CR: Disappearance of all TL and Non-TL. All lymph nodes must be non-pathological in size (\< 10 mm in SAD). PR: Tumor load of the TL is reduced by =\<30% compared to the baseline, or in the case of complete remission of the TL, when one or more, Non-TL can still be distinguished.SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum LD since the treatment started. SD have to be maintained for at least 24 days (around 4 weeks) after the TAK-103 infusion.

DCR was defined as the percentage of participants whose best overall response was iCR, iPR and iSD or better as determined by the investigator per iRECIST. iCR: Disappearance of all TL and Non-TL. All lymph nodes must be non-pathological in size (\< 10 mm in SAD). iPR: Tumor load of the TL is reduced by =\<30% compared to the baseline, or in the case of complete remission of the TL, when one or more, non-TL can still be distinguished. iSD: Determined if the criteria of iCR or iPR are not met and no tumor progression is present.

DOR was defined as the time from the date of first documentation of a PR or better to the date of first documentation of PD per RECIST version 1.1. PR: At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).

DOR was defined as the time from the date of first documentation of an iPR or better to the date of first documentation of disease progression per iRECIST. iPR: Tumor load of the TL is reduced by =\<30% compared to the baseline, or in the case of complete remission of the TL, when one or more, non-TL can still be distinguished.

TTP was defined as the time from the TAK-103 infusion date to the date of first documented disease progression by the investigator per RECIST version 1.1.

TTP was defined as the time from the TAK-103 infusion date to the date of first documented disease progression by the investigator per iRECIST.

PFS was defined as the time from the TAK-103 infusion date to the date of disease progression per RECIST version 1.1 or death from any cause, whichever occurred first.

PFS was defined as the time from the TAK-103 infusion date to the date of disease progression per iRECIST or death from any cause, whichever occurred first.

OS was defined as the time from the TAK-103 infusion date to the date of death from any cause. Participants who did not die were censored at the last known survival follow-up.

Number of participants with RCR-Positive test results were reported.