NCT06182579

Phase I Dose-Escalation Study of RiMO-401 With Radiation in Advanced Tumors

Extracted Fields (from Registry)
Protocol IDNCT06182579
Registration Date2023-12-27
StatusTerminated
SponsorCoordination Pharmaceuticals, Inc.
CountryUnited States
Industryindustry
Blindingunblinded
Center Typesingel-center RCT
Scopenational RCT
First Patient In2024-02-22
Last Patient Out2025-06-16
Publicationn
Gender %ALL
Mean Age18 Years -
LLM Classifications (Side-by-Side)
Field OPENAI
gpt-4o
Thinking: o3
3053ms / 8661 tok 		CLAUDE
claude-sonnet-4-20250514
Thinking: claude-opus-4-20250514
5013ms / 10105 tok 		GLM
glm-5.1
7200ms / 8825 tok 		Review
rct_type N/A N/A N/A OK
cancer_status Cancer Cancer Cancer OK
non_cancer_spec N/A N/A N/A OK
setting_patient outpatient outpatient outpatient OK
setting_place hospital hospital other –
feasibility N/A fully powered RCT → N/A
shaky reasoning
✓ Unanimous Initial: fully powered RCT Requery: N/A — This is a Phase I dose-escalation study, which is not an RCT but rather a preliminary safety and dosing study.
 N/A feasibility RCT → N/A
shaky reasoning
✓ Unanimous Initial: feasibility RCT Requery: N/A — This is a Phase I dose-escalation study focused on determining tolerability and recommended dose, not a randomized controlled trial.
 N/A OK
intervention_pharmacologic yes yes yes OK
intervention_chemo_immuno_radio yes yes yes OK
intervention_complementary no no no OK
intervention_device no no no OK
intervention_psychological no no no OK
intervention_complex no no → no → yes
shaky reasoning
✗ No consensus Initial: no Requery: no — The intervention involves a single modality of treatment (drug + radiation) without interactive components from different categories. Thinking: yes — The intervention combines a pharmacologic agent (RiMO-401) with radiotherapy, two distinct treatment modalities from different categories delivered together.
 yes yes → yes → no
shaky reasoning
✗ No consensus Initial: yes Requery: yes — The intervention combines two distinct treatment modalities - pharmacologic (intratumoral drug injection of RiMO-401) and radiation therapy - that work together as an integrated treatment approach. Thinking: no — This is a combination therapy (drug + radiation) but not a complex intervention as both are medical treatments co-administered for a single therapeutic purpose.
 no
intervention_acp no no no OK
intervention_music no no no OK
intervention_screening no no no OK
intervention_palliative no yes → no
shaky reasoning
✓ Unanimous Initial: yes Requery: no — The trial tests a drug (RiMO-401) with palliative radiation as a setting, not as the intervention itself.
 no no → no
shaky reasoning
✓ Unanimous Initial: no Requery: no — This is a drug trial testing RiMO-401 with radiation in advanced cancer patients, where palliative radiation is the setting/context, not the intervention being studied.
 no OK
intervention_education no no no OK
intervention_digital no no no OK
intervention_other no no no OK
outcome_symptom no no no OK
outcome_qol no no no OK
outcome_dignity no no no OK
outcome_cost no no no OK
outcome_other yes yes yes OK
pharmacologic_sub not yet FDA/EMA approved other → not yet FDA/EMA approved
shaky reasoning
✓ Unanimous Initial: other Requery: not yet FDA/EMA approved — RiMO-401 is described as being in a Phase I clinical trial, indicating it is an investigational drug not yet approved by FDA or EMA.
 not yet FDA/EMA approved not yet FDA/EMA approved → not yet FDA/EMA approved
shaky reasoning
✓ Unanimous Initial: not yet FDA/EMA approved Requery: not yet FDA/EMA approved — RiMO-401 appears to be an experimental/investigational drug being tested in a Phase I dose-escalation study to determine tolerability and recommended dose.
 not yet FDA/EMA approved OK
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