Phase 2 Randomized Clinical Trial Comparing the Safety and Efficacy of PULSAR-Integrated Radiotherapy + Pembrolizumab or Nivolumab Administered With or Without STING-Agonist IMSA101 in Patients With Oligoprogressive Solid Tumor Malignancies
Patients shall be enrolled in 2 treatment arms as follows:
1. 15 patients in the control arm (PULSAR-ICI alone)
2. 30 patients in the experimental arm (PULSAR-ICI + IMSA101)
PULSAR-ICI with or without IMSA101 treatment will be administered to the patients in Cycles
1, 2, and 3, and thereafter only standard of care ICI monotherapy will be administered to all
patients. Each treatment cycle will be 28 days in duration for Cycles 1, 2 and 3, then per
standard of care monotherapy thereafter based on the product labels of the prescribed ICI.
The study will start with a safety run-in portion at 2 dose levels for the experimental arm,
followed by a randomized portion for both treatment arms. The safety run-in shall employ a
3+3 safety run-in component.
All patients will be followed throughout the study for drug tolerability and safety by
collecting clinical and laboratory data, including adverse events (AEs) using Common
Terminology Criteria for Adverse Events (CTCAE) Version 5.0 criteria, SAEs, concomitant
medications, and vital signs.
All patients will be assessed for anti-tumor efficacy at screening, prior to the end of Cycle
3, and at 8-week intervals thereafter based on radiographic assessments (all outcome measures
per RECIST Version 1.1 and iRECIST).
Tumor types and the corresponding treatment combinations to be evaluated will be identified
prior to the first patient enrolled.
All patients will continue to receive their assigned treatment throughout the study until the
occurrence of disease progression (based on iRECIST), death, or other unacceptable
treatment-related toxicity, or until the study is closed by the sponsor.
Elacestrant Monotherapy vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer Following CDK4/6 Inhibitor Therapy: A Phase 3 Randomized, Open-label, Active-controlled, Multicenter Trial
This is an international, multicenter, randomized, open-label, active-controlled,
event-driven, Phase 3 clinical study comparing the efficacy and safety of elacestrant to the
SoC options of fulvestrant or an aromatase inhibitor (AI) in postmenopausal women and in men
with advanced or metastatic ER+/HER2- breast cancer, either in subjects with tumors that
harbor mutations in the ligand binding domain (LBD) of the estrogen receptor 1 (ESR1) gene
(ESR1-mut subjects) or in all subjects regardless of ESR1 status (ESR1-mut and ESR1 wild type
[ESR1-WT]) and whose disease has relapsed or progressed on at least one and no more than two
prior lines of endocrine therapy (with documented progression), which must have included
prior CDK4/6 inhibitor therapy in combination with fulvestrant or an aromatase inhibitor (AI)
and for whom hormonal monotherapy with one of the SoC drugs (fulvestrant, anastrozole,
letrozole, exemestane) is an appropriate treatment option.
An Open Label Multicentre Phase 1 Study of Oral IGF-1R Inhibitor PL225B in Subjects With Advanced Refractory Solid Tumors.
An open label multicentre Phase 1 study of oral IGF-1R inhibitor PL225B in subjects with
advanced refractory solid tumors. This is a dose-finding trial using the modified Accelerated
Titration Design with 3 new subjects per cohort and 100% dose increments in the accelerated
phase followed by standard phase with 40% dose increments.Subjects will receive study drug on
a daily basis for twenty-one (21) days according to the dose and schedule specified for a
particular cohort of therapy. Toxicity profile of the drug will be assessed during Cycle 1 of
subject treatment in each cohort for determination of Maximum Tolerated Dose (MTD) according
to the schedule given below.
Not recruiting | Any Cancer Condition or Solid Tumor | Multisite
A Phase 1 Study of AGEN1181, an Fc-Engineered Anti-CTLA-4 Monoclonal Antibody as Monotherapy and in Combination With AGEN2034 (Balstilimab), an Anti-PD-1 Monoclonal Antibody, in Subjects With Advanced Cancer
This Phase 1 study will enroll up to approximately 550 evaluable adult participants with
refractory, advanced cancer (solid tumors).
The study will consist of a 3+3 dose escalation. Different dose levels of botensilimab, both
monotherapy and in combination with balstilimab, will be evaluated in individual cohorts
based upon dose. Each participant will remain in the cohort of the dose level and schedule
assigned at study entry. Participants can be replaced for any reason other than a
dose-limiting toxicity (DLT). Participants will receive treatment for ≤ 2 years or until
progressive disease, unacceptable toxicity, or any criterion for stopping the study drug or
withdrawal of trial occurs.
Additionally, the study is intended to further explore the safety, PK, PD, and clinical
activity in selected cancer types at dose levels (botensilimab monotherapy and combination
therapy with balstilimab) determined as potentially effective. Indications of interest
include, but are not limited to, non-small-cell lung cancer, melanoma, endometrial cancer,
ovarian cancer, angiosarcoma, colorectal cancer without liver metastases, prostate cancer,
and fibrolamellar carcinoma.
A Phase I/II Trial of Temsirolimus Plus Neratinib for Patients With Metastatic HER2-Amplified or Triple Negative Breast Cancer
Phase I Design
A standard, 3+3, dose escalation schedule will be used. Between 6 and 12 patients will
likely be necessary to determine the MTD of temsirolimus in combination with neratinib.
There will be no intrapatient dose escalation. The starting dose of temsirolimus is 8 mg
administered intravenously weekly (dose level 1). Three patients will initially be enrolled
in each cohort. The Phase I portion is closed to enrollment.
Phase II Design
The phase II portion of this trial will be comprised of two cohorts—HER2-amplified and
triple negative breast cancer—each of which has a Simon two-stage design to determine the
efficacy of temsirolimus when administered in combination with neratinib. Both pathologic
subtypes of patients will be studied separately though accrual will be simultaneous.
Response (RECIST criteria) will be assessed every 8 weeks (every 2 cycles) after the start
of therapy. As of 2/10/12, the Triple-negative cohort is closed to accrual. The HER2-
amplified cohort will continue to enroll as planned up to a total of 34 patients.
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