Clinical Study of Bioactivity of Low Dose Apalutamide in Prostate Cancer Patients Scheduled for Prostatectomy
PRIMARY OBJECTIVE:
I. To determine the effects of low dose apalutamide on circulating levels of prostate
specific antigen (PSA).
SECONDARY OBJECTIVES:
I. To determine the effect of low dose apalutamide on:
Ia. Reversibility of testosterone levels 7-14 days post intervention; Ib. Post-intervention
plasma trough apalutamide concentration; Ic. Health-related quality of life.
EXPLORATORY OBJECTIVE:
I. To determine the effects of apalutamide on intra-prostatic immune cell infiltration and
Gleason score and the effects of tobacco/alcohol use on the study endpoints.
OUTLINE:
Patients receive apalutamide orally (PO) on study. Patients also undergo collection of blood
samples throughout the study.
After completion of the trial intervention, patients are followed up at 7-10 days, 60 days,
and 3 months post-prostatectomy.
A Dose Finding Phase 1 of Sarilumab Plus Capecitabine in HER2/Neu-Negative Metastatic Breast Cancer and a Single-arm, Historically-controlled Phase 2 Study of Sarilumab Plus Capecitabine in Stage I-III Triple Negative Breast Cancer With High-Risk Residual Disease (EMPOWER)
The study will consist of two phases, I and II.
Phase I will include patients with metastatic TNBC, HER2/neu-negative and hormone resistant
breast cancer. A total of 4 doses of sarilumab will be given with the starting dose of 150 mg
SQ at 3-weeks cycles given 3 days prior to each of the first 4 of 8 cycles of capecitabine
(1000 mg/m2/BID; for 14 days every 21 days). If dose escalation is possible, sarilumab will
be administered every 3 weeks at 200 mg SQ for 4 doses. Blood samples will be obtained prior
during the course of treatment. Bone marrow samples are optional.
Phase II is a single arm study in Stage I to III TNBC with less than a complete pCR after
neoadjuvant therapy evaluating the combination of sarilumab with capecitabine (1000mg/m2/BID;
for 14 days every 21 days) as compared to historical control patients treated with
capecitabine alone. There are 8 cycles of capecitabine. The first 4 cycles will be combined
with sarilumab. The Phase II sarilumab dose will be determined by the Phase I best tolerated
dose. Blood samples will be obtained prior during the course of treatment. Bone marrow
samples are optional.
A pilot parallel biological baseline study of standard adjuvant capecitabine in stage I to
III TNBC with less than a pCR will be performed. This Arm will be open in parallel with both
Phases 1 and 2. Blood samples will be obtained prior during the course of treatment. Bone
marrow samples are optional.
A Phase I Study of In Situ Immunomodulation With CDX-301, Radiotherapy, CDX-1140, and Poly-ICLC in Patients With Unresectable and Metastatic Solid Tumors With Injectable Palpable Disease
PRIMARY OBJECTIVE:
I. To evaluate the safety profile of in situ immunomodulation with recombinant Flt3 ligand
(CDX-301), radiotherapy, agonistic anti-CD40 monoclonal antibody CDX-1140, and Poly-ICLC in
unresectable and metastatic melanoma, cutaneous squamous cell carcinoma, Merkel cell
carcinoma, high-grade bone and soft tissue sarcoma or breast cancer patients with injectable
palpable disease by determining the maximum tolerated dose (MTD) of CDX-1140 that has an
acceptable adverse event profile.
SECONDARY OBJECTIVE:
I. To evaluate the immune signatures in the tumor microenvironment before and after in situ
immunomodulation with CDX-301, radiotherapy, CDX-1140, and Poly-ICLC.
EXPLORATORY OBJECTIVES:
I. To record the overall response rate (ORR) (complete response [CR] and partial response
[PR]) of injected as well as distant uninjected metastatic lesions in metastatic melanoma,
cutaneous SCC, Merkel cell carcinoma, high-grade bone and soft tissue sarcoma or breast
cancer patients with injectable palpable disease treated with in situ immunomodulation with
CDX-301, radiotherapy, CDX-1140, and Poly-ICLC by immune-related Response Evaluation Criteria
In Solid Tumors (irRECIST) response assessment, and compare intratumoral alone versus (vs.)
intratumoral + intravenous administration of CDX-1140.
II. To record the overall survival (OS) and progression free survival (PFS) in unresectable
and metastatic melanoma, cutaneous SCC, Merkel cell carcinoma, high-grade bone and soft
tissue sarcoma or breast cancer patients with injectable palpable disease treated with in
situ immunomodulation with CDX-301, radiotherapy, CDX-1140, and Poly-ICLC, and compare
intratumoral alone vs. intratumoral + intravenous administration of CDX-1140.
III. Examine changes in the levels of T-cell subsets/myeloid derived suppressor cells
(MDSC)/cytokines in peripheral blood (PB) of unresectable and metastatic melanoma, cutaneous
SCC, Merkel cell carcinoma, high-grade bone and soft tissue sarcoma or breast cancer patients
with injectable palpable disease treated with in situ immunomodulation with CDX-301,
radiotherapy, CDX-1140, and Poly-ICLC.
OUTLINE:Cohort A will evaluate safety of intratumoral administration of CDX-1140 in
combination with CDX-301, radiotherapy and Poly-ICLC. Once cohort A is finished, patients
will be enrolled to cohort B to evaluate safety of intratumoral + intravenous administration
of CDX-1140 in combination with CDX-301, radiotherapy and Poly-ICLC.
COHORT A: Patients receive recombinant Flt3 ligand intratumorally (IT) on days 1-5 and
agonistic anti-CD40 monoclonal antibody CDX-1140 IT with Poly-ICLC IT on day 9 or 10.
Patients also undergo radiation therapy on day 8 or 9. Treatment repeats every 21 days for 4
cycles in the absence of disease progression or unacceptable toxicity.
COHORT B: Patients receive recombinant Flt3 ligand IT on days 1-5 and agonistic anti-CD40
monoclonal antibody CDX-1140 IT and intravenously (IV) over 90 minutes with Poly-ICLC IT on
day 9 or 10. Patients also undergo radiation therapy on day 8 or 9. Treatment repeats every
21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then every 3-6
months for 2 years.
A Phase 1/2a Open Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of AFM24 in Combination With Atezolizumab in Patients With Selected Advanced/Metastatic EGFR-expressing Cancers
There will be 2 parts in this study: a dose escalation phase (phase 1) and an expansion phase
(phase 2a). Patients will qualify to receive the investigational drugs (AFM24 + atezolizumab)
in the dose escalation phase or the expansion phase only if they are deemed eligible
following the safety lead-in phase. Seven days before the planned first combination
treatment, patients will receive a single dose of AFM24 and will be observed for any adverse
events for 1 week.
The aim of the dose escalation phase is to determine the maximum tolerated dose
(MTD)/recommended phase 2 dose (RP2D) of AFM24 in combination with atezolizumab.
The dose escalation phase will be followed by the expansion phase once the MTD/RP2D of AFM24
in combination with atezolizumab has been determined. The expansion phase of the study is
intended to collect preliminary evidence of efficacy and to further confirm the safety of
AFM24 in combination with atezolizumab.
The tumor types planned to be studied in the AFM24/atezolizumab combination study will be:
- Non-small cell lung cancer (EGFR-WT), with disease progression after chemotherapy and
PD1/PD-L1 targeted therapy
- Gastric/GEJ cancer if intolerant to or with disease progression after standard
platinum-based chemotherapy
- Pancreatic/hepatocellular/biliary tract cancer with disease progression after standard
of care (SOC) therapy or if there is no appropriate SOC available for their condition
- Advanced or metastatic NSCLC harboring a targetable EGFR kinase domain mutation with
disease progression on or after received ≥1 prior lines of treatment for advanced
disease, including a Tyrosine-Kinase Inhibitor (TKI) for EGFR mutations
A Phase 1a/b Study of ADRX-0706 in Subjects With Select Advanced Solid Tumors
This is a 2 part study. The Phase 1a will consist of a dose escalation of ADRX-0706 to
evaluate initial safety and tolerability in patients with select advanced solid tumors, and
to identify the recommended dose to be used in the Phase 1b. The Phase 1b will further
evaluate the safety and tolerability, as well as preliminary efficacy, and identify the
optimal dose of ADRX-0706 in 3 disease-specific expansion cohorts.
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