Hani M. Babiker, M.D.

The purpose of this dose escalation study is to evaluate the safety profile of escalating doses and dose schedules of NXP900.

This is an open-label phase 1 study with an escalation part and an expansion part.

The purpose of part one of this study is to determine the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and safety profile of Q901 monotherapy when administered via intravenous (IV) infusion once-weekly (QW) for 4 weeks and once every 2 weeks (Q2W) thereafter. Also, to establish for future clinical development the recommended Phase 2 dose (RP2D) of Q901 monotherapy when administered via IV infusion QW for 4 weeks and Q2W thereafter. 

The purpose of part two of this study is to evaluate safety and tolerability and evidence of anticancer activity of Q901 as monotherapy and in combination with pembrolizumab. In Part 2 Cohort 1, an expansion phase at the established RP2D will be undertaken in participants with selected advanced solid tumors. In Part 2 Cohort 2, a safety run in and expansion phase will be undertaken with Q901 at the RP2D administered in combination with pembrolizumab (400 mg Q6W) in participants with advanced solid tumors.

The purpose of this study is to to characterize the safety, tolerability, and pharmacokinetics of MRTX1719 in patients with advanced solid tumor malignancies with MTAP (methylthioadenosine phosphorylase) deletion.

TNG462-C102 is a Phase 1/2, open-label, multicenter study designed to determine the safety, tolerability, PK, PD, and preliminary antineoplastic activity of oral TNG462 in combination with RMC-6236 or RMC-9805. The study comprises a dose escalation phase and a dose expansion phase.

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors combined with Standard(s) of Care (SOC) or with novel agents. The first three subprotocols include the following: Subprotocol A: RMC-6236 + 5-fluorouracil-based regimens Subprotocol B: RMC-6236 + cetuximab with or without mFOLFOX6 Subprotocol C: RMC-6236 + gemcitabine + nab-paclitaxel

The study is being conducted to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of 3HP-2827 in the treatment of unresectable or metastatic solid tumors with FGFR2 alterations. Patients will be enrolled in two stages: dose escalation stage (Stage I) and expansion stage (Stage II).

The purpose of this study is to determine long-term safety of previous treatment with applicable cell and gene therapy products

The purpose of this study is to evaluate AZD5851 in patients with GPC3+ advanced/recurrent hepatocellular carcinoma.

The purpose of this study is to assess the safety and efficacy of BMS-986504, a selective, MTA-cooperative PRMT5 inhibitor, in combination with Nab-paclitaxel/Gemcitabine (nab-p/gem) versus placebo in combination with nab-p/gem, in participants with untreated metastatic Pancreatic Ductal Adenocarcinoma (PDAC) with homozygous methylthioadenosine phosphorylase (MTAP) deletion.

The purpose of this study is to determine if LIF (Leukemia Inhibitory Factor) level is positively correlated with disease progression and CA19-9 level in Pancreatic Ductal Adenocarcinoma (PDAC) patients and is a reliable biomarker of response.

The purpose of this study is to evaluate whether profiling aggressive tumors for molecular alterations, together with drug testing in patient-derived 3D models, can provide crucial information for the identification of specific therapeutic targets. Additionally, immunoprofiling of microcancer model systems is crucially necessary data to enable prediction of immunotherapeutic efficacy. We postulate that our innovative approach will establish much needed immune microenvironment information and facilitate the identification of specific sensitivity profiles and biomarker signatures that correlate response to targeted agents (or combinations) with particular tumor profiles.

The purpose of this study is to determine the preliminary anti-tumor activity and confirm the safety of VV1 in combination with Cemiplimab. The study will enroll patients with three distinct separate tumor cohorts. The cancers types are colorectal, head and neck carcinoma, and melanoma that are progressing on CPI treatment. Currently the study is enrolling only to the HNSCC cohort.

The purpose of this study is to characterize the safety and tolerability of single agent HFB301001 and to determine recommended dose expansino (RDE(s) and a recommended Phase 2 dose (RP2D).

The purpose of this study is to define the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D), safety profile, pharmacokinetics (PK), pharmacodynamics and preliminary anti-tumor activity of RLY-4008 in patients with ICC and other advanced solid tumors. 

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of BJ-005 in patients with advanced solid tumor or lymphoma. BJ-005 is a recombinant bifunctional molecule, composed of a humanized anti-PD-L1 IgG1 monoclonal antibody (mAb) fused with a portion of the extracellular domain of human TGF-β receptor II (TGF-βRII).

The purpose of this study is to determine the single-agent EO-3021 recommended phase 2 dose (RP2D) and schedule for further exploration in patients with advanced solid tumors that are likely to express CLDN18.2.

The purpose of this study is to evaluate JSI-1187 as monotherapy and in combination with dabrafenib for the treatment of advanced solid tumors with MAPK pathway mutations, including mutations that cause MAPK pathway hyperactivation.

The purpose of this study is to assess the effects of DCSZ11, an anti-CD93 monoclonal antibody, as a monotherapy in patients with advanced or metastatic solid tumors.

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary effectiveness of KIN-3248, an oral small molecule FGFR inhibitor, in adults with advanced tumors harboring FGFR2 and/or FGFR3 gene alterations.

The purpose of this study is to establish the safety and tolerability, and to determine the recommended Phase 2 dose (RP2D) for LYT-200.

The purpose of this study is to evaluate the safety, tolerability, and preliminary effectiveness of ZB131 in patients with solid tumors where prevalence of CSP expression is high. 

The purpose of this first in human study in patients with deleted Methylthioadenosine phosphorylase (MTAP) advanced or metastatic solid tumors is to detertamine dose escalation in part one and dose expansion in specific MTAP-deleted tumor types. 

The purpose of this study is to determine if a new molecule that targets natural killer (NK) cells and T-cell activation signals to specific receptors on cancer cells. The study will occur in two phases. The first phase will be a dose escalation phase, enrolling patients with various types of solid tumors that express epidermal growth factor receptor (EGFR). A combination therapy cohort will be opened for enrollment, DF9001 + nivolumab. The second phase will include a dose expansion using the best dose selected from the first phase of the study. Multiple cohorts will be opened with eligible patients having selected solid tumors.

The purpose of this study is to evaluate the safety and tolerability of ivosidenib in combination with nivolumab and ipilimumab and determine the recommended combination dose (RCD) of ivosidenib, nivolumab, and ipilimumab.

The purpose of this study is to determine the recommended Phase 2 dose (RP2D) of TBio-6517 when administered by direct injection into tumor(s) alone and when combined with pembrolizumab in patients with solid tumors (RIVAL-01).

The purpose of this study is to evaluate the effectiveness and safety of pemigatinib versus gemcitabine plus cisplatin chemotherapy in first-line treatment of participants with unresectable or metastatic cholangiocarcinoma with FGFR2 rearrangement.

This study considers the safety and tolerability of increasing doses of CX-4945 in combination with gemcitabine plus cisplatin to determine the maximum tolerated dose (MTD), followed by a randomized study that compares antitumor activity in cholangiocarcinoma patients receiving the standard of care gemcitabine plus cisplatin versus CX-4945 at the combination MTD with gemcitabine plus cisplatin.

The purpose of this study is to evaluate M7824 monotherapy in participants with advanced or metastatic biliary tract cancer (BTC) who failed or were intolerant to first-line (1L) chemotherapy.

The purpose of this study is to evaluate whether bintrafusp alfa in combination with the current standard of care (SoC) (gemcitabine plus cisplatin) improves overall survival (OS) or progression-free survival (PFS) in chemotherapy and immunotherapy-naïve participants with locally advanced or metastatic BTC compared to placebo, gemcitabine and cisplatin.

The purpose of this study is to evaluate how well gemcitabine hydrochloride and cisplatin given with or without nab-paclitaxel work in treating patients with newly diagnosed biliary tract cancers that have spread to other places in the body. Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin, and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not known if giving gemcitabine hydrochloride and cisplatin with or without nab-paclitaxel may work better at treating biliary tract cancers.

The purpose of this study is to assess the efficacy and safety of tiragolumab, an anti-TIGIT monoclonal antibody, when administered in combination with atezolizumab and bevacizumab as first-line treatment, in participants with unresectable, locally advanced or metastatic hepatocellular carcinoma (HCC).

The purpose of this global study is to evaluate transarterial chemoembolization (TACE) in combination with durvalumab and bevacizumab therapy in patients with locoregional hepatocellular carcinoma.

The purpose of this study is to assess the effictiveness and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy in participants with BTC after surgical resection with curative intent.

This pivotal, open-label, single-arm study will evaluate the anti-cancer activity of ARQ 087 by Objective Response Rate (ORR) by central radiology review as per RECIST v1.1 in subjects with inoperable or advanced intrahepatic cholangiocarcinoma (iCCA) whose tumors harbor FGFR2 gene fusions (by FISH performed by the central laboratory) and who received at least one prior regimen of systemic therapy. Subjects will be dosed orally once per day at 300 mg of ARQ 087 capsules.

The purpose of this study is to assess the effectiveness and safety of durvalumab plus tremelimumab combination therapy and durvalumab monotherapy versus sorafenib in the treatment of patients with no prior systemic therapy for advanced HCC. The patients cannot be eligible for locoregional therapy.

This is a multicenter, open-label, stratified, randomized study to evaluate the safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of MEDI4736 (Durvalumab) in combination with tremelimumab, MEDI4736 monotherapy or tremelimumab monotherapy in subjects with unresectable hepatocellular carcinoma.

The primary objectie of Safety Run-In Cohort (Cohort 1) is to evaluate the safety and tolerability of multiple intratumoral injections (IT) of VG161 at the recommendated Phase 2 Dose (RP2D) in patients with HCC and ICC who have either disease progression or intolerable toxicity after the standard treatments.

The primary objective of HCC Cohort (Cohort 2) is to evaluate the efficacy of multiple IT injections of VG161 in patients with hepatocellular carcinoma (HCC).

The primary objective of ICC Cohort (Cohort 3) is to evaluate the efficacy of multiple IT injections of VG161 in patients with intrahepatic cholangiocarcinoma.

This is an open-label, non-randomized, multicenter, multinational, Phase 2 study exploring the effectiveness and safety of neratinib as monotherapy or in combination with other therapies in patients with ERBB mutation-positive or EGFR gene-amplified solid tumors.

The purpose of this study is to assess the safety of a specific treatment regimen (protein-bound Paclitaxel, Cisplatin, And Gemcitabine (GCN)) combined with a device called Tumor Treatment Fields (TTF) in preventing tumor growth in paitents with recurrent recurrent and/or metastatic pancreatic cancer (met-PC).

This multicenter, non-randomized, open-label study will evaluate the efficacy and safety of six treatment regimens in participants with advanced solid tumors for whom therapies that will convey clinical benefit are not available and/or are not suitable options per the treating physician's judgment.

The purpose of this study is to evaluate the safety, tolerability, and anti-tumor activity of STP707 with IV administration in subjects with advanced/metastatic or surgically unresectable solid tumors who are refractory to standard therapy.

This is a Phase 1 / 2 open-label study to assess the safety and tolerability of APL-101, to determine the RP2D and dose limiting toxicities for APL-101, and to obtain preliminary efficacy in subjects
with c-Met dysregulation in advanced malignancies and Non-Small Cell Lung Cancer (NSCLC). c-Met dysregulation will be determined by local/archival molecular pre-screening evaluations for eligibility of enrollment.
Mayo Clinic will be participating in both Part A (Phase 1) & (Phase 2) B of the study.

The purpose of this study is to determine the overall rate of response of brain metastases in subjects with central nervous system (CNS) metastases due to metastatic melanoma with a BRAF V600 mutation who have relapsed or progressed from initial or systemic disease.

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The purpose of this study is to test the effectiveness and safety of Tumor Treating Fields (TTFields), in combination with gemcitabine and nab-paclitaxel, for front line treatment of locally-advanced pancreatic denocarcinoma.The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.