Clinical trial · Interventional
Study of AR-67 (Formerly DB-67) in Adult Patients With Refractory or Metastatic Solid Malignancies
A Phase I Study of DB-67 (7-t-butyldimethylsilyl-10-hydroxycamptothecin) in Adult Patients With Refractory or Metastatic Solid Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Hypothesis: AR-67 (formerly DB-67) represents a rationally engineered drug that possesses improved stability, toxicity, and efficacy compared to current Food and Drug Administration (FDA)-approved camptothecins, based on the extensive research of prior studies. Therefore, the investigators hypothesize that AR-67 (formerly DB-67) will be well-tolerated and efficacious in phase I clinical trials. This initial phase I trial will establish the maximum tolerated dose in humans, establish the toxicity profile, and define the appropriate dose of AR-67 (formerly DB-67) for future phase II and III clinical trials.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tumors | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AR-67 (formerly DB-67) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- I
- description
- Dose escalating
- interventionNames
- Drug: AR-67 (formerly DB-67)
Primary outcomes (2)
- measure
- Maximum tolerated dose (MTD)
- timeFrame
- Any time during the four 21-day cycles
- measure
- Dose limiting toxicity (DLT)
- timeFrame
- Any time during the four 21-day cycles
Secondary outcomes (2)
- measure
- Pharmacokinetics
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * \>18 year old subjects with solid malignancies that have progressed after at least one prior chemotherapy regimen and have exhausted other therapies * Treated and clinically stable brain metastases * Measurable OR non-measurable disease * Greater than three weeks since surgery * Normal organ and marrow function * ECOG Performance Status of \< 2 * No other prior malignancy except for treated basal cell or squamous cell skin cancer, in situ cervical cancer, Stage I or II cancer (patient in complete remission) or other cancer from which the patient has been disease-free for 5 years. * Computed tomography (CT) scan of involved areas within 28 days of registration * Life expectancy of greater than 12 weeks. Exclusion Criteria: * Pregnant or nursing females * Chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) of entering the study. * Patients may not be receiving any other investigational agent. Uncontrolled intercurrent illness including active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Allergic reactions to compounds of similar chemical or biologic composition to DB-67 (i.e. camptothecins such as irinotecan, topotecan, or others of this class of pharmaceuticals). * Subjects with prior anaphylactic injection reaction of \> grade 3 to paclitaxel or any other product formulated with cremophor * Subjects with HIV
References
Publications (0)
Data not yet available