Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SPLIT Abs · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part 1 (Dosimetry) | EXPERIMENTAL | Participants will receive SeParated v-domains LInkage Technology Antibodies (SPLIT Abs) administered intravenously (IV). During Cycle 1, following an initial dosing interval, participants will receive 203Pb-DOTAM for imaging-based dosimetry assessment, followed by administration of 212Pb-DOTAM. In other cycles, participants will receive SPLIT Abs in combination with 212Pb-DOTAM only. Treatment will be administered every 4 weeks (Q4W) for up to 6 cycles. Each cycle is 28 days. |
| Part 2 (212Pb-DOTAM Administered Activity Escalation) | EXPERIMENTAL | Participants will receive SPLIT Abs at the dose and dosing interval selected in Part 1 in combination with 212Pb-DOTAM. The administered activity of 212Pb-DOTAM will be increased stepwise in each cohort to identify the maximum tolerated administered 212 activity (MTA) or a recommended Phase 2 administered activity (RP2A). |
| Part 3 (Expansion) | EXPERIMENTAL | Participants will receive SPLIT Abs in combination with 212Pb-DOTAM at the RP2A identified based on results from Parts 1 and 2. |
| Name | Type | Description |
|---|---|---|
| SPLIT Abs | DRUG | Participants will receive SPLIT Abs as part of the pretargeting regimen per the schedule described in the protocol. |
| 203Pb-DOTAM | DRUG | Participants will receive 203Pb-DOTAM as an imaging surrogate per the schedule described in the protocol. |
| 212Pb-DOTAM | DRUG | Participants will receive 212Pb-DOTAM as a therapeutic radioligand per the schedule described in the protocol. |
Inclusion Criteria: * Histologically confirmed adenocarcinoma originating from the colon or rectum * Metastatic disease (Stage IV American Joint Committee on Cancer, Version 7) * Confirmed MSS and/or proficient mismatch repair (MMR) status * Experienced disease progression during or within 3 months...
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SPLIT Abs is an investigational small molecule being studied for the treatment of metastatic colorectal cancer (mCRC). It is currently in Phase 1 clinical development, with an active trial recruiting participants in the United States. The drug is not yet approved and remains under investigation for this indication.
SPLIT Abs is being developed by Roche Holding AG, a biopharmaceutical company traded under the ticker RHHBY. The company is conducting a Phase 1 clinical trial to evaluate the drug in patients with metastatic colorectal cancer.
SPLIT Abs is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is actively recruiting participants to study its safety and effects in metastatic colorectal cancer.
SPLIT Abs is being evaluated in a single Phase 1 clinical trial with the identifier NCT07416552. The study, titled "A Study to Investigate CEA-PRIT 2.0 in Participants With Metastatic Colorectal Cancer (mCRC)," is recruiting 180 participants aged 18 years and older in the United States.
Yes, SPLIT Abs is also known as CEA-PRIT 2.0. The Phase 1 clinical trial for the drug is titled "A Study to Investigate CEA-PRIT 2.0 in Participants With Metastatic Colorectal Cancer (mCRC)," confirming that these names refer to the same investigational therapy.