Phase 1 Dose Escalation and Dose Expansion Trial of NP-101 in Patients With Solid Tumors
ConditionSolid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
To evaluate the safety and preliminary efficacy of NP-101 in patients with solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years.
Must be willing and able to provide informed consent.
Ability to comply with the study protocol, in the investigator's judgment.
Histologically documented advanced or metastatic solid tumor that has relapsed or progressed following local standard treatments that are known to prolong survival, or for which no standard treatment is available.
Disqualifiers
History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drug.
Unresolved toxicities from prior therapy (defined as having not resolved to NCI CTCAE v.5.0 Grade ≤1 or baseline). Exceptions include endocrinopathies from prior therapy or disease and successfully treated (such as hypothyroidism, diabetes mellitus), alopecia, vitiligo, and Grade ≤2 peripheral neuropathy. Patients may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to Grade >2 for at least 3 months prior to Cycle 1, Day 1 and managed with standard of care treatment) that the investigator deems related to previous toxicities from prior immunotherapy treatment.
Patients who are receiving any other investigational agents.
Unable to swallow and retain oral medications.
Trial design
Design model
Single group
Treatments tested in this trial
NP-101
DrugGiven by mouth
Treatment groups
35 Participants
are divided into 2 treatment groupsGroup A: Dose EscalationExperimental treatment 1 intervention
Group B: Dose ExpansionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame
Through study completion; an average of 1 year.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
M.D. Anderson Cancer Center
Lead sponsor
Novatek Pharmaceuticals, Inc.
Collaborator
Source ClinicalTrials.gov