A Randomized Phase 2 Trial of Atezolizumab and Bevacizumab in Combination With SRF388 or Placebo in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma
This is a Phase 2 trial designed to evaluate the efficacy and safety of SRF388 in combination
with atezolizumab plus bevacizumab (Arm A) compared to placebo in combination with
atezolizumab plus bevacizumab (Arm B) in patients with first-line advanced or metastatic HCC.
After a Lead-In Phase of up to 30 patients who will receive open-label SRF388 + atezolizumab
+ bevacizumab, the blinded Randomized Phase will randomize approximately 104 patients with a
1:1 allocation to Arm A or Arm B and stratified by geographic region (Asia excluding Japan
vs. rest of world) and Barcelona Clinic Liver Cancer (BCLC) stage (B or C).
A Phase I, First-in-human, Open-label, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP 1454
Primary Objective:
• To establish the MTD and/or Recommended Phase 2 Dose (RP2D) of orally administered TP-1454
in patients with metastatic solid tumors and anal cancer.
Secondary Objectives:
- To establish the pharmacokinetic (PK) profile of orally administered TP-1454
- To observe patients for any evidence of antitumor activity of TP 1454 by objective
radiographic assessment
- To assess the safety and tolerability of TP-1454
A Phase 1/2 Study of LY3537982 in Patients With KRAS G12C-Mutant Advanced Solid Tumors
This is an open-label, multicenter Phase 1/2 study to evaluate safety, tolerability, and
preliminary efficacy of oral LY3537982 in patients with KRAS G12C-mutant solid tumors.
This study will be conducted in 3 parts: Phase 1a dose escalation, Phase 1b dose expansion
and dose optimization, and Phase 2.
KRAS G12C mutations will be identified through standard of care testing.
A Phase 1/2 Safety Study of Intratumorally Administered INT230-6 in Adult Subjects With Advanced Refractory Cancers
INT230-6 is comprised of a 3 agents in a fixed ratio - a cell permeation enhancer and two,
potent anti-cancer payloads (cisplatin and vinblastine sulfate). The penetration enhancer
facilitates dispersion of the two drugs throughout injected tumors and enables increased
diffusion into cancer cells. (Nonclinical safety studies showed no findings following drug
injection into healthy tissues.)
Historically physicians administer the two active drugs comprising INT230-6 by intravenous
(IV) infusion to achieve a systemic blood level at the limit of tolerability. The objective
is destroy both visible tumors and unseen circulating cancer cells (micro-metastases).
Unfortunately, dosing drugs IV delivers only a small amount with a low concentration at the
tumor site. This approach especially for late stage cancers is not highly effective and often
quite toxic to the patient.
Attempts at direct intratumoral injection with chemotherapeutic agents have not shown the
ability to treat the injected tumor, non-injected tumors or micro-metastases. This lack of
efficacy for local administration is due possibly to poor dispersion and a lack of cell
uptake of the agents.
Due to the use of the novel cell penetration enhancing agent INT230-6 treatment demonstrates
strong efficacy in animals having large tumors. The Sponsor's in vivo, non-clinical data
shows that INT230-6 thoroughly saturates and kills injected tumors. In addition, the drug
induces an adaptive (T-cell mediated) immune response that attacks not only the injected
tumor, but non-injected tumors and unseen micro-metastases. Cured animals become permanently
immunized against the type of cancer that INT230-6 eliminates.
Clinical trial IT-01 seeks to determine the safety and potential efficacy of dosing INT230-6
directly into several different types of cancers. In addition animal studies showed a strong
synergy of INT230-6 with immune modulation agents. Thus as part of study IT-01 the Sponsor
seeks to understand the safety and efficacy of INT230-6 when administered in combination with
immuno-therapeutic agents such as antibodies that target Programmed Cell Death (PD-1 or
anti-PD-1) and Cytotoxic T-Lymphocyte Associated Protein 4 (CTLA-4 or anti-CTLA-4) receptors.
This study seeks to understand whether tumor regression can be achieved and patient outcomes
improved.
Phase I/II First-in-Human Study of TT-10 as a Single Agent in Subjects With Advanced Selected Solid Tumors
Multicenter, open-label dose-escalation Phase I/II clinical study, designed to evaluate the
safety, tolerability, PK, PD, anti-tumor activity, and efficacy of TT-10 in subjects
diagnosed with advanced Renal cell cancer (RCC), castrate resistant prostate cancer (CRPC)
and Non-small cell lung cancer (NSCLC); who have failed or are not eligible for standard of
care treatment.
The study will be conducted in two phases. Dose escalation (Phase 1) will be to determine the
maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D), safety and tolerability of
TT-10 in subjects with advanced subjects diagnosed with advanced Renal cell cancer (RCC),
castrate resistant prostate cancer (CRPC) and Non-small cell lung cancer (NSCLC); who have
failed or are not eligible for standard of care treatment. Dose expansion (Phase 2) will be
to further explore the safety and tolerability of the MTD and/or RP2D, PK, PD, anti-tumor
activity, and efficacy of TT-10.
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